Medical Policy: 08.01.24
Original Effective Date: September 2016
Reviewed: June 2020
Revised: June 2020
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 syndrome (DES), dry eye disease, or dysfunctional tear syndrome, either alone or in combination with other conditions, is a frequent cause of ocular irritation that leads patients to seek ophthalmologic care. DES is considered a significant public health problem. It is estimated to affect between 14% and 33% of the population worldwide. The prevalence of DES increases with age, especially in postmenopausal women. It is estimated that DES affects more than 7 million Americans older than 40 years of age, and approximately 1 to 4 million Americans between 65 to 84 years of age. Prevention and treatment of DES are expected to be of greater importance as the population ages.
Dry eye can occur when basal tear production decreases, tear evaporation increases, or tear composition is imbalanced. Factors that can contribute to dry eye include the following:
DES is often classified into the aqueous-deficient subtype or the evaporative subtype, although classification is not mutually exclusive. DES 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. Current treatment options for MGD include physical expression to relieve the obstruction, administration of heat (warm compresses) to the eyelids to liquefy solidified Meibomian gland (MG) contents, eyelid scrubs to relieve external meibomian gland orifice blockage, and medications (eg, antibiotics, topical corticosteroids) to mitigate infection and inflammation of the eyelids. These treatment options, however, have shown limited clinical efficacy. For example, physical expression can be very painful given the amount of force needed to express obstructed glands. Warm compress therapy can be time-consuming and labor intensive, and there is limited evidence that medications relieve MGD. While the symptoms of DES often improve with treatment, the disease usually is not curable and may lead to substantial patient and physician frustration. Dry eyes can be a cause of visual morbidity and may compromise results of corneal, cataract, and refractive surgery. Inadequate treatment of DES may result in increased ocular discomfort, blurred vision, reduced quality of life, and decreased productivity.
Currently, the diagnosis of dry eye syndrome is via a comprehensive eye exam including:
The first line of treatment in patients complaining of dry eye are:
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.
Interferometry is a non-invasive technique for recording tear film surface irregularities. While this technique has been used to diagnose DE, it is hindered by natural eye movements resulting in measurement noise. Currently, there is insufficient evidence to support the use of interferometry for the diagnosis of DE as a consequence of Meibomian gland dysfunction or other causes. Meibography is the imaging and study of the morphology (structure and function) of meibomian glands. Near-infrared dual imaging uses reflective and transilluminated light purportedly to improve meibography techniques (ie, reduce time and discomfort) and enhance results. The LipiView II and the LipiScan are examples of meibography devices capable of ocular surface interferometry.
A dual-paddle heating device has been developed (MiBo Thermoflo; MiBo Medical Group, Dallas, Texas, US) which can warm, massage, and empty clogged Meibomian glands on both upper and lower lids simultaneously.
TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. It is stated by the manufacturer that it delivers an effective, non-invasive and drug-free way to temporarily increase tear production.
InflammaDry is a test for human tears. Per the package insert: is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
The serum of a patient's blood can be formulated into eye drops. There is not strong evidence for long-term or significant benefit over artificial tears. Access to these eye drops and cost are additional barriers to their use.
Intra-ductal meibomian gland probing is a novel technique to address DES, although its use has not been described in the guidelines on management of disease. Future research is needed to study Meibomian gland probing changes in a randomized controlled clinical trial (RCT).
The TearCare® system is intended as an alternative to warm compresses to reduce dry eye disease 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 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.
In 2013, the American Academy of Ophthalmology published preferred practice patterns guidelines on dry eye syndrome, A number of treatment options were recommended. The use of thermal pulsation treatment devices was not mentioned.
American Academy of Ophthalmology (AAO, 2018) The AAO states “no single test is adequate for establishing the diagnosis of dry eye” and recommends that the combination of findings from diagnostic tests can be useful to understanding a patient’s condition. The guideline covers the currently used diagnostic tests, which are as follows: assessment of tear osmolarity, MMP9, tear production, fluorescein dye or tear function index, tear break up time, ocular surface dye staining, and lacrimal gland function.
Eyelid thermal pulsation therapy, devices for evacuating Meibomian glands via heat and/or pressure (e.g. Lipiflow®, MiBo Thermoflo) to treat dry eye syndrome is considered investigational.
Tear film imaging (e.g., LipiView Ocular Surface Interferometer) is considered investigational because its clinical value has not been established.
Infared imaging/Near-infrared dual imaging of the Meibomian glands to diagnose dry eye syndrome/Meibomian gland dysfunction is considered investigational
Tear immunoassay point of care testing is considered investigational.
Autologous tears/autologous serum for the treatment of dry eye is considered investigational
Enzyme-based treatement (e.g. DNase) for the treatment of dry eye is considered investigational
Meibomian gland probing is considered investigational.
The trials of thermal pulsation, intranasal neurostimulation (e.g. Lipiflow, Thermoflo and TrueTear) do not provide strong evidence of long-term efficacy. The guidelines for the management of dry eye syndrome do not mention these modalities for treatment at this time. There is not strong evidence for long-term or significant benefit over artificial tears. There is a lack of FDA approval for enzyme-based treatment at this time.
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.