Medical Policy: 08.01.24
Original Effective Date: September 2016
Reviewed: June 2021
Revised: June 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Dry eye disease (DED) is a multifactorial disease of the ocular surface with loss of homeostasis of the tear film and ocular symptoms. Tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. DED is also known as keratoconjunctivitis sicca, dry eye syndrome (DES), and dysfunctional tear syndrome.
In epidemiological studies performed globally, the prevalence of dry eye syndrome (DES) ranges from 5 to 50 percent. Based on data from the National Health and Wellness Survey, 6.8 percent of the United States adult population (approximately 16.4 million people) have been diagnosed with DES. The prevalence increased with age (2.7 percent in those 18 to 34 years old versus 18.6 percent in those ≥75 years old) and was higher in women than men (8.8 versus 4.5 percent).
Risk Factors for DES include:
Dry eye syndrome (DES), particularly when severe, can have a significant impact on visual acuity, daily activities, social and physical functioning, and workplace productivity.
DES has a complex and multifactorial etiology. The tear film of the eye consists of aqueous, mucous, and lipid components. A healthy tear film relies on a synergistic interaction of the lacrimal glands, eyelids, and ocular surface, which together comprise the lacrimal functional unit. Dysfunction of any component in the lacrimal functional unit can lead to DES.
DES has been classified into two general groups: decreased tear production (resulting in aqueous deficient DES) and abnormal meibomian gland physiology (resulting in evaporative DES). However, it is now believed that both mechanisms are present in most patients, although one may be predominant. For all patients, tear film hyperosmolarity and subsequent ocular surface inflammation lead to the variety of symptoms and signs associated with DES.
Symptoms in DES result from activation of sensory nerves of the ocular surface, either due to tear hyperosmolarity, the presence of inflammatory mediators, or hypersensitivity of the sensory nerves.
Most patients will present with symptoms of chronic eye irritation associated with mild to moderate discomfort. However, there is considerable variability in patient-reported symptoms and clinically measurable signs over time, as well as a recognized lack of correlation between these signs and symptoms. Common eye complaints include:
Due to the variability of findings on clinical evaluation of dry eye syndrome (DES), some clinicians base their assessment of DES on the results of validated questionnaires. These can also be used for monitoring DES and can be useful for standardizing the identification and classification of DES.
Available questionnaires used specifically for the evaluation of DES symptoms include:
The diagnosis of dry eye syndrome (DES) is based on characteristic patient symptoms and supporting findings on the physical examination, both of which can vary considerably in intensity over time and under different environmental conditions.
There is no single diagnostic test or set of tests to confirm or rule out DES. Examples of methods often used to evaluate ocular surface include, but are not limited to:
Current treatment for DES is aimed at improving symptoms by increasing or supplementing tear production, slowing tear evaporation, reducing tear resorption, or reducing ocular surface inflammation. In addition to symptomatic relief, treatment with artificial tears may improve visual acuity and prevent against ocular damage.
First line treatments may include the following:
Other treatments are available for DES and are discussed below.
The purpose of therapy in patients who have dry eye syndrome (DES) is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The relevant population of interest is individuals with dry eye syndrome (DES). DES is often classified into the aqueous-deficient subtype or the evaporative subtype, although classification is not mutually exclusive. Dry eye syndrome is a multifactorial disease of the ocular surface that may require a combination approach to treatment. Meibomian gland dysfunction (MGD), characterized by changes in gland secretion with or without concomitant gland obstruction, is recognized as the most common cause of evaporative dry eye and may also play a role in aqueous-deficient dry eye.
The therapy being considered is LipiFlow Thermal Pulsation System, iLux Thermal Pulsation System, Systane iLux2 Thermal Pulsation System, intranasal neurostimulation (TureTear), autologous eye drops (autologous serum tears), intraductal probing (Maskin Device), intense pulsed light (IPL) and electrothermal heat (TearCare System).
The following practices are currently being used to treat dry eye syndrome (DES): standard treatment with warm compresses and eyelid massage. Current treatment options for meibomian gland dysfunction (MGD) include physical expression to relieve the obstruction, administration of heat (warm compresses) to the eyelids to liquefy solidified meibomian gland contents, eyelid scrubs to relieve external meibomian gland orifice blockage, and medications (eg, antibiotics, topical corticosteroids) to mitigate infection and inflammation of the eyelids.
The general outcomes of interest are symptoms, morbid events, and functional outcomes.
The LipiFlow Thermal Pulsation System (TearScience) is a new device developed to address the limitations of current treatment options to relieve MGD. This device is designed to heat the palpebral surfaces of both the upper and lower eyelids, while applying graded pulsatile pressure to the outer eyelid surfaces. The LipiFlow® System is composed of a disposable ocular component and a handheld control system. Following application of a topical anesthetic, the heated inner portion of the LipiFlow eyecup is applied to the conjunctival surface of the upper and lower eyelids. The outer portion of the device covers the skin surface of the upper and lower eyelids. The device massages the eyelids with cyclical pressure from the base of the Meibomian glands in the direction of the gland orifices, thereby expressing the glands during heating. It is proposed that a single 12-minute session is at least as effective as twice daily lid warming and massage over 3 months.
In 2017 and 2020, two eyelid thermal pulsation systems (iLux® System and Systane iLux2®) were also cleared by the FDA. These devices were identified by FDA as a "battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids. The device provides controlled warmth to the inner eyelid surface, close to the location of the meibomian glands, and intermittent massage to the outer eyelid surface to facilitate release of lipid from the cystic meibomian glands." The devices are indicated for "the application of localized heat and pressure therapy in adult patients with meibomian gland dysfunction (MGD), which is associated with evaporative dry eye." The Systane iLux2® system is also indicated "to capture/store digital images and video of the meibomian glands."
For individuals who have dry eye syndrome (DES) who receive LipiFlow eyelid thermal pulsation, the evidence includes 4 randomized controlled trials (RCTs,) a nonrandomized comparison study, and longer- term follow-up of patients from RCTs and observational studies. The trials do not provide strong evidence of long-term efficacy. Two RCTs have demonstrated positive findings for most outcome measures over the short term (up to 3 months). Observational studies have shown sustained treatment effects for most outcomes up to 3 years. The nonrandomized study showed similar outcomes for eyelid thermal pulsation and standard treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
TrueTear is a handheld stimulator with a prolonged hydrogel-containing disposable tip with a reusable cover. The tip provides the contact for conducting the stimulation current, produced by the base unit, to the target site inside the nasal passages. The device is inserted into the nostrils where a tingling sensation is felt. The stimulation intensity is adjustable, and the device automatically turns off after one minute. The process purports to stimulate a nerve that innervates the lacrimal glands, causing tear production. The device has a usage limit of 30 minutes in a 24- hour period and the disposable tip should be discarded after 24 hours. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Autologous eye drops (autologous serum tears) have been proposed for dry eye syndrome (DES) and are made by mixing the individual’s serum with other substances. There is not strong evidence for long-term or significant benefit over artificial tears and access to these eye drops and the cost are additional barriers to its use. Additional large, high-quality RTCs are needed in different severities of dry eye and using standardized questionnaires to measure participant-reported outcomes and objective clinical tests as well as objective biomarkers to assess the benefit of autologous eye drops (autologous serum tear) therapy for (DES). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Intra-ductal probing is performed using local or topical anesthetic and introduces a thin stainless-steel wire probe into the meibomian gland orifices to forcefully expel any obstructing material and restore patency. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
The TearCare® system is intended as an alternative to warm compresses to reduce dry eye syndrome (DES) symptoms caused by meibomian gland blockages. The system comprises four components: a smart hub to control thermal energy emission, a charger for the hub, two pairs of single-use thermal emitters (SmartLid™ devices), and a single use, blunt-tipped, tweezer-like device (Clearance Assistant™).
An optometrist or ophthalmologist delivers the TearCare treatment during an office visit. The clinician applies the SmartLid devices to the patient’s upper and lower eyelids over the meibomian glands and activates the hub. The connected emitters heat the eyelids to 41°C to 45°C for 12 minutes. During treatment, patients keep their eyes open and blink normally; blinking is intended to help clear meibomian gland obstructions and re-lubricate eyes. After removing emitters, the clinician applies a drop of 0.5% tetracaine to each eye and expresses any remaining meibomian gland blockages from the patient’s eyelids using the Clearance Assistant. The system is currently undergoing clinical trials. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Delivers bursts of light at specific wavelengths. The light energy is converted to heat. IPL therapy has been suggested as a treatment for DES. While study results of intense pulsed light therapy treatment for dry eye syndrome (DES) caused by meibomian gland dysfunction (MGD) may be promising, further multi-center clinical trials with a larger sample, treatment comparison groups, and randomized controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
In 2018, the American Academy of Ophthalmology (AAO) updated preferred practice patterns guidelines on dry eye syndrome (DES). These guidelines list "In-office, physical heating and expression of the meibomian glands (including device-assisted therapies, such as LipiFlow, or intense pulse light treatment)" as 1 of several step-up treatments for patients who do not respond to conventional management, including the elimination of environmental factors and offending medications, dietary modifications, ocular lubricants, and lid hygiene and warm compresses.
In 2018, the American Academy of Ophthalmology updated preferred practice patterns guidelines on blepharitis. These guidelines cover the three clinical subcategories of blepharitis: staphylococcal, seborrheic, and meibomian gland dysfunction (posterior blepharitis specifically affects the meibomian glands). The following statements are made relevant to thermal pulsation treatment:
"There are also several in-office procedural treatments available that may theoretically unclog the inspissated meibomian gland orifices using intense pulsed light (IPL) or mechanical means (e.g., microblepharoexfoliation of the eyelid margin, meibomian gland probing, and/or devices using thermal pulsation). Although there have been industry-sponsored studies, independent, randomized, masked clinical trials have yet to be performed to assess efficacy of these costly, primarily fee-for-service treatments.”
In 2011, the LipiFlow® Thermal Pulsation System (TearScience; assigned the generic name of eyelid thermal pulsation system) was cleared by the U.S. Food and Drug Administration (FDA). In 2017 and 2020, 2 eyelid thermal pulsation systems (iLux® System and Systane® iLux2®, respectively) were also cleared by the FDA. The FDA classified these devices as class II (special controls) to provide a “reasonable assurance of safety and effectiveness” of the device. All 3 devices were identified by FDA as a "Battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids. The device provides controlled warmth to the inner eyelid surface, close to the location of the meibomian glands, and intermittent massage to the outer eyelid surface to facilitate release of lipid from the cystic meibomian glands." All 3 devices are indicated for "the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye." The Systane® iLux2® system is also indicated "to capture/store digital images and video of the meibomian glands."
The following diagnostic tests are considered investigational for the diagnosis of dry eye syndrome (DES), because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome:
Therapies including but not limited to the following for the treatment of dry eye syndrome (DES) due to decreased tear production and/or increased evaporation loss is considered investigational, because the evidence is insufficient to determine that the technology results in an improvement in the net health outcome:
To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.