Medical and/or Vision Insurance plans do not cover the Specialty Dry Eye Testing or LipiFlow services.

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1 ADVANCED BENEFICIARY NOTICE (ABN) Patient s Name: Date of Birth: The purpose of this form is to help you make an informed choice about your visit today. Before you make a decision about your options, you should read this entire notice carefully. Medical and/or Vision Insurance plans do not cover the Specialty Dry Eye Testing or LipiFlow services. You will be responsible for 100% of all fees for each procedure. The following items are NOT covered by any insurance. You are responsible for these charges: Items or Services: Cost: Specialty Dry Eye Testing $ LipiFlow Both Eyes $ I have read and understand the above statement and agree to pay for all services, and understand that my insurance will not be billed for the procedures listed above. Preliminary and aftercare follow-up visits can be billed to insurance will be billed. I am responsible for any copays and co-insurance and understand that any amounts billed can be applied towards deductibles. Specialty Dry Eye Testing Signature: Date: LipiFlow Signature: Date:

2 INSURANCE ELIGIBILITY DETAILS FOR THE FDA APPROVED LIPIFLOW THERMAL PULSATION PROCEDURE The information below provides an overview of the coding and insurance billing for treatment of: Meibomian Gland Dysfunction Disease (MGD) and Evaporative Dry Eye & Blepharitis with FDA approved LipiFLOW Thermal Pulsation Procedure (CPT Code 0207T). Insurance Coverage: LipiView & LipiFlow are Non-Covered Services. As we are preferred Providers for many insurance carriers, we have confirmed LipiView Surface Imaging and LipiFlow Thermal Pulsation Procedure are not covered services per current insurance guidelines and general medical provider contracts. Therefore, Specialty Eyecare Group will not bill the insurance carrier, request a pre-certification or prior-authorization regarding LipiView or LipiFlow treatment as this is deemed inappropriate by both parties given established non-coverage status. LipiView Surface Imaging and LipiFlow Thermal Pulsation Procedure are categorized as elective services. Overall, this means Insurance carriers do not recognize either LipiView diagnostic or LipiFlow treatment and will not pay or cover service fees. Patients choosing to have LipiView and/or LipiFlow are financially responsible for their service and treatment fees (see fees below). Checking For Your Plan s Coverage: Upon checking personal benefits and coverage for LipiView and LipiFlow with your insurance Customer Service Representatives for insurance carriers are required to respond to elective treatments, or procedures, without established coverage or reimbursement with request for prior authorization, a referral, or precertification with chart notes or clinicals. Prior-Authorizations WILL NOT be submitted by Specialty Eyecare Group due to established non-coverage of the elective medical services for LipiView and LipiFlow. Regardless, these submissions WILL NOT change the status of non-covered services to a covered service. Patients wishing to submit treatment services to their insurance carrier may do so, however, it is Specialty Eyecare Group policy that we WILL NOT submit elective treatment billing with non-established benefits under any circumstance. Therefore, Insurance will not be billed by Specialty Eyecare Group for elective testing and treatment/services given non-coverage status. Fees for LipiView testing and/or LipiFlow treatment are collected on the day of service. Patients may choose to personally submit their treatment information and clinicals to their providers. Documentation will be made available to requesting patients. Methods of Payment: Cash, Check, Credit Cards: Mastercard, Visa HSA & Flexible Spending Eligible: You may choose to use your pre-tax flexible spending funds or health savings account for LipiView and LipiFlow services. Diagnosis Codes: Evaporative Dry Eye: code Blepharitis (inflammatory meibomian gland lid condition): code Treatment codes: CPT Code: 0330T LipiView: Tear film imaging, unilateral or bilateral, with interpretation and report. $ CPT Code: 0207T LipiFlow: Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral. Single: $ Both Eyes: $ Insurance coding: LipiFlow is categorized with a level III (3) CPT Code. Category 3 CPT codes are temporary codes and automatic denial. Category 3 codes are used to represent emerging services and procedures like FDA approved LipiFlow. Please sign below to acknowledge that you have read and understand this form. Signature Date

3 David L. Kading, OD, FAAO, FCLSA Kristi Kading, OD, FAAO, FCOVD Katherine Shen, OD Charissa Young, OD Patient Name: Date: - - Dry Eye Questionnaire How frequently do you experience any of these dry eye symptoms? Never Sometimes Often Constant Dryness, Grittiness or Scratchiness Soreness or Irritation Burning or Watering Eye Fatigue How severe are your dry eye symptoms? No problems Tolerable Uncomfortable Bothersome Intolerable Unable to perform my daily tasks Dryness, Grittiness or Scratchiness Soreness or Irritation Burning or Watering Eye Fatigue IN OFFICE USE ONLY BELOW SEG DEQ (SPEED) Score Meiboscale: OD: 0 = 0% 1 = 25% 2 = 25-50% 3 = 50-75% 4 = % NE 128 th St. Suite 1, Kirkland, WA th Ave, Seattle, WA p / f p / f

4 David L. Kading, OD, FAAO, FCLSA Kristi Kading, OD, FAAO, FCOVD Katherine Shen, OD Charissa Young, OD OS: 0 = 0% 1 = 25% 2 = 25-50% 3 = 50-75% 4 = % NE 128 th St. Suite 1, Kirkland, WA th Ave, Seattle, WA p / f p / f

5 Ocular Surface Disease Index (OSDI ) 2 Ask your patient the following 12 questions, and circle the number in the box that best represents each answer. Then, fill in boxes A, B, C, D, and E according to the instructions beside each. HAVE YOU EXPERIENCED ANY OF THE FOLLOWING DURING THE LAST WEEK: All of Most of Half of Some of None of 1. Eyes that are sensitive to light? Eyes that feel gritty? Painful or sore eyes? Blurred vision? Poor vision? Subtotal score for answers 1 to 5 (A) HAVE PROBLEMS WITH YOUR EYES LIMITED YOU IN PERFORMING ANY OF THE FOLLOWING DURING THE LAST WEEK: All of Most of Half of Some of None of 6. Reading? N/A 7. Driving at night? N/A 8. Working with a computer or bank machine (ATM)? N/A 9. Watching TV? N/A Subtotal score for answers 6 to 9 HAVE YOUR EYES FELT UNCOMFORTABLE IN ANY OF THE FOLLOWING SITUATIONS DURING THE LAST WEEK: All of Most of Half of Some of None of 10. Windy conditions? N/A 11. Places or areas with low humidity (very dry)? N/A 12. Areas that are air conditioned? N/A (B) Subtotal score for answers 10 to 12 (C) ADD SUBTOTALS A, B, AND C TO OBTAIN D (D = SUM OF SCORES FOR ALL QUESTIONS ANSWERED) TOTAL NUMBER OF QUESTIONS ANSWERED (DO NOT INCLUDE QUESTIONS ANSWERED N/ A) (D) (E) Please turn over the questionnaire to calculate the patient s final OSDI score.

6 PATIENT INFORMATION FOR LIPIFLOW TREATMENT (Treatment for Meibomian Gland Dysfunction / Evaporative Dry Eye) The information in this document is to help you decide whether or not to have a LipiFlow Treatment. Please carefully read this document in its entirety. Ask your doctor any questions that you may have about the information in this document prior to having a LipiFlow Treatment. INTRODUCTION The surface of the eye is covered in a lining of tears called the tear film. The tear film is made up of three layers: a Lipid (oil) layer which lubricates and prevents evaporation of the tears; an Aqueous (water) layer, which nourishes and protects the eye surface; and a Mucin layer, which adheres to the eye. Since the tear film is exposed directly to the air, the protective lipid layer is essential to maintaining a healthy tear film on the eye. When the protective lipid layer of the tear film is lacking, the eye surface can become irritated and dry eye symptoms can occur. Evaporative Dry Eye is a disease that results from not having enough lipid in the tear film to protect the eye. Evaporative dry eye is most often caused by a blockage or obstruction of the eyelid glands, called the Meibomian Glands, which produce the lipid layer of the tear film. Meibomian Gland Dysfunction is a disease that results from the formation of plugs inside the glands, which obstruct gland openings and limit the lipid secreted by the glands into the tears. WHAT IS THE LIPIFLOW SYSTEM? The LipiFlow System is a medical device used by a doctor to apply heat and pressure to the eyelids to allow the lipids from the blocked eyelid glands to flow into the tear film. Your doctor will determine if the LipiFlow System is an appropriate treatment option you based on a complete exam of your eye health, including evaluation for blocked glands and associated dry eye symptoms. WHAT ARE THE INDICATIONS FOR LIPIFLOW TREATMENT? The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. WHAT ARE ALTERNATIVE TREATMENTS FOR MGD AND EVAPORATIVE DRY EYE? Possible alternative treatments for MGD and evaporative dry eye include: Manual expression of your eyelid glands by your doctor. Warm compress therapy and eyelid hygiene using scrubs and manual massage. Topical prescription medications Over-the-counter tear replacements and lubricants for dry eye. Punctal plugs made of silicone or collagen inserted in the tear ducts. Cauterization (sealing) of the opening of the tear duct in the eye. WHAT SHOULD I EXPECT DURING A LIPIFLOW TREATMENT? The 12-minute treatment will begin with you either resting in a reclined chair or lying comfortably on a table in a procedure room. Your doctor will place 1-2 drops of a mild anesthetic in the eye(s) to be treated. Your doctor will gently fit the LipiFlow (Disposable) eyepiece under your eyelids. You will be asked to close your eyes gently around the eyepiece and keep them closed. The LipiFlow will be activated. You will begin to feel both gentle pressure and warmth on your eyelid. The eyepiece will become gradually warmer on your eyelids. Once the temperature reaches a therapeutic range, the device will maintain this temperature for 2 minutes at a constant pressure. This is when the glands are being brought to the appropriate temperature to begin melting the blockages within the glands. At the end of the 2 minutes, the pressure will be released briefly. Next, the temperature will be maintained but the pressure will go through different modes, including slow increasing pressure and pulsation, for several cycles throughout the remaining 10 minutes of treatment. This is done to facilitate removing the blockages from the glands. WHAT ARE THE CONTRAINDICATIONS OF THE LIPIFLOW TREATMENT? The LipiFlow System should not be used in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions. Ask your doctor if you have any of the following conditions. Recent eye surgery, eye injury or a Herpes infection of the eye of eyelid, or chronic recurrent eye inflammation within the prior 3 months 1

7 Current eye infection or eye inflammation Eyelid abnormality that affects eyelid function Eye surface abnormality that may affect the integrity of the eye surface WHAT ARE THE PRECAUTIONS REGARDING LIPIFLOW TREATMENT? The eyepiece used for treatment (Disposable) may not fit all eyes, such as eyes with small eyelid anatomy. Use of the LipiFlow System is not recommended in patients with the following conditions. Patients with these conditions may have reduced treatment effectiveness because these conditions may cause eye symptoms unrelated to cystic meibomian glands. Safety and effectiveness of the device have not been studied in patients with these conditions. Ask your doctor if you have any of the following conditions. Moderate to severe allergy in the eye Severe eyelid inflammation. Patients with severe eyelid inflammation should be treated medically prior to device use. Systemic disease conditions that cause dry eye Taking medications known to cause dryness In addition, the treatment procedure may loosen previously inserted punctual plugs, which may worsen the patient s dry eye symptoms. WHAT ARE THE WARNINGS REGARDING LIPIFLOW TREATMENT? You should be aware of the following warnings related to the LipiFlow System. Federal law restricts this device to sale by or on the order of a licensed physician. You should be under direct supervision during the entire length of treatment Remove contact lenses prior to treatment. You can resume contact lens wear one hour after completion of treatment unless there is an adverse effect, as determined by you and your doctor. In the event of an adverse effect such as, eye surface irritation, inflammation or discomfort, your doctor will advise you when to resume contact lens wear following resolution of the effect. Do not to attempt to remove the eyepiece (Disposable) from your eye during treatment Keep your eyelids closed during treatment. If your eyelids are not closed, the eyepiece (Disposable) will not be in the proper position to provide appropriate treatment of your eyelids. In case of discomfort, your doctor can reduce the pressure applied to your eyelids or pause the treatment at any time. WHAT ARE THE RISKS AND POTENTIAL ADVERSE EFFECTS OF THE LIPIFLOW TREATMENT? There is no guarantee that you will receive any medical benefit as a result of the LipiFlow treatment. It is possible that your dry eye symptoms and blocked eyelid glands will improve. It is also possible that your condition will remain the same or worsen. Potential adverse effects that may occur as a result of the procedure include, but are not limited to the onset or increase in: Eyelid or eye pain requiring discontinuation of the treatment procedure; Eyelid irritation or inflammation (for example, eyelid swelling, itching, stye); Eye surface irritation or inflammation (for example, scratch on the eye surface, swelling of the eye surface or eye redness); and Eye symptoms (for example, burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light). Potential serious adverse events that are not anticipated because of the device mitigations to prevent occurrence include: Heat-related injury to the eyelid or eye; Physical pressure-induced injury to the eyelid; and Eye surface infection. In addition, the LipiFlow treatment may involve risks that are unforeseeable. There is always the possibility that you will have an adverse event or problem that is currently unknown and unexpected. You should discuss any questions or concerns you might have with your doctor. If you experience any problems during the treatment, it is important that you tell your doctor. Patient s Name: Signature: Date: 2

Medical and/or Vision Insurance plans do not cover the Specialty Dry Eye Testing or LipiFlow services.

Medical and/or Vision Insurance plans do not cover the Specialty Dry Eye Testing or LipiFlow services. ADVANCED BENEFICIARY NOTICE (ABN) Patient s Name: Date of Birth: The purpose of this form is to help you make an informed choice about your visit today. Before you make a decision about your options, you