Medical Policy: 08.01.24 

Original Effective Date: September 2016 

Reviewed: June 2020 

Revised: June 2020 

 

Notice:

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 Application:

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.

 

Description:

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.

 

Causes of Dry Eye

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:

  • Medications including antihistamines, decongestants, antidepressants, birth control pills, hormone replacement therapy to relieve symptoms of menopause, and medications for anxiety, Parkinson’s disease, and high blood pressure have been associated with dry eye.
  • Advancing age is a risk factor for declines in tear production. Dry eye is more common in people age 50 years or older.
  • Rosacea (an inflammatory skin disease) and blepharitis (an inflammatory eyelid disease) can disrupt the function of the Meibomian glands.
  • Autoimmune disorders such as Sjögren’s syndrome, lupus, scleroderma, and rheumatoid arthritis and other disorders such as diabetes, thyroid disorders, and Vitamin A deficiency are associated with dry eye.
  • Women are more likely to develop dry eye. Hormonal changes during pregnancy and after menopause have been linked with dry eye. Women also have an increased risk for autoimmune disorders.
  • Windy, smoky, or dry environments increase tear evaporation.
  • Seasonal allergies can contribute to dry eye.
  • Prolonged periods of screen time encourage insufficient blinking.
  • Laser eye surgery may cause temporary dry eye symptoms. 

 

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:

  • Patient history to determine the patient's symptoms and to note any general health problems, medications or environmental factors that may be contributing to the dry eye problem.
  • External examination of the eye, including lid structure and blink dynamics.
  • Evaluation of the eyelids and cornea using bright light and magnification.
  • Measurement of the quantity and quality of tears for any abnormalities. 

 

First line treatments

The first line of treatment in patients complaining of dry eye are:

  • Tear supplementation
  • Environmental coping strategies
  • Amelioration of eyelid abnormalities including blepharitis
  • Application of warm compresses (to soften secretions in obstructed meibomian gland excretory ducts)
  • Discontinuation of systemic or ocular medications that can contribute to dryness, if possible

 

The LipiFlow® Thermal Pulsation System

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.

 

MiBo Thermoflo

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.

 

Intranasal neurostimulation (ie, TrueTear)

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

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.

 

Autologous serum tears

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.

 

Meibomian Gland Probing

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).

 

TearCare

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.

 

Guidelines and Position Statements

American Academy of Ophthalmology

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.

 

Prior Approval:

Not applicable

 

Policy:

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.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 0207T Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral.
  • 0330T Tear film imaging, unilateral or bilateral, with interpretation and report.
  • 0507T Near-infrared dual imaging (ie, simultaneous reflective and trans-illuminated light) of Meibomian  glands, unilateral or bilateral, with interpretation and report
  • 0563T Evacuation of meibomian glands, using heat delivered through wearable, open-eye eyelid treatment devices and manual gland expression, bilateral
  • 68899 Unlisted procedure, lacrimal system

 

Selected References:

  • Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care. Dec 2011;17 Suppl 16:S432-439. PMID 22435675
  • The definition and classification of dry eye disease: report of the Definition and ClassificationSubcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. Apr 2007;5(2):75-92. PMID 17508116
  • American Academy of Opthalmology. Dry Eye Syndrome Preferred Practice Pattern Guidelines – Limited Edition 2011
  • American Academy of Ophthalmology. Dry Eye Syndrome, Preferred Practice Pattern Guideline 2013
  • Medical devices; ophthalmic devices; classification of the eyelid thermal pulsation system. Final rule. Fed Regist. Aug 19 2011;76(161):51876-51878. PMID 21894651
  • Lane SS, DuBiner HB, Epstein RJ, et al. A new system, the LipiFlow, for the treatment of Meibomian gland dysfunction. Cornea. Apr 2012;31(4):396-404. PMID 22222996
  • Zhao Y, Veerappan A, Yeo S, et al. Clinical trial of thermal pulsation (Lipiflow) in meibomian gland dysfunction with preteatment meibography. Eye Contact Lens. Jan 27 2016. PMID 26825281
  • Finis D, Hayajneh J, Konig C, et al. Evaluation of an automated thermodynamic treatment (LipiFlow(R)) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. Ocul Surf. Apr 2014;12(2):146-154. PMID 24725326
  • Greiner JV. Long-Term (3 Year) Effects of a Single Thermal Pulsation System Treatment on Meibomian Gland Function and Dry Eye Symptoms. Eye Contact Lens. Mar 2016;42(2):99-107. PMID 26222095
  • Blackie CA, Coleman CA, Holland EJ. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthalmol. 2016;10:1385-1396. PMID 27555745
  • Hagen, KB, Bedi, R, Blackie, CA, and Christenson-Akagi, KJ. Comparison of a single-dose vectored thermal pulsation procedure with a 3- month course of daily oral doxycycline for moderate-to-severe meibomian gland dysfunction. Clin Ophthalmol. 2018;12:161-168. PubMed: 29398903
  • Blackie, CA, Coleman, CA, Nichols, KK, Jones, L, Chen, PQ, Melton, R, Kading, DL, O'Dell, LE, et al. A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day. Clin Ophthalmol. 2018;12:169-183. PubMed: 29398904
  • Geerling, G & Baudouin, Christophe & Aragona, Pasquale & Rolando, Maurizio & Boboridis, Kostas & M. Benítez-del-Castillo, José & A. Akova, Yonca & Merayo-Lloves, Jesus & Labetoulle, Marc & Steinhoff, Martin & Messmer, Elisabeth. (2017). Emerging strategies for the diagnosis and treatment of meibomian gland dysfunction: Proceedings of the OCEAN group meeting. The Ocular Surface. 15. 10.1016/j.jtos.2017.01.006.
  • C. Mun, S. Gulati, S. Tibrewal, Y. Chen, Seungwon An, et al. A Phase I/II Placebo-Controlled Randomized Pilot Clinical Trial of Recombinant Deoxyribonuclease (DNase) Eye Drops Use in Patients With Dry Eye Disease. Translational Vision Science & Technology, 2019; 8 (3): 10 DOI: 10.1167/tvst.8.3.10
  • Marko Oydanich, Maureen G. Maguire, Maxwell Pistilli, Pedram Hamrah, Jack V. Greiner, Meng C. Lin, Penny A. Asbell. (2019) Effects of Omega-3 Supplementation on Exploratory Outcomes in the Dry Eye Assessment and Management Study. Ophthalmology.
  • Joel A. Silbert, Etty Bitton, Kriti Bhagat. (2019) Advances in Diagnosis and Management of Dry Eye Disease. Advances in Ophthalmology and Optometry 4, 13-38
  • Blackie CA, Coleman CA, Holland EJ. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clin Ophthalmol. Jul 26 2016; 10:1385-1396. PMID 27555745
  • Greiner JV. Effects of a single thermal pulsation system treatment on meibomian gland function and dry eye symptoms. Eye Contact Lens. Mar 2016; 42(2):99-107. PMID 26222095
  • National Eye Institute: Dry Eye
  • Akpek, E. K., Amescua, G., Farid, M., Garcia-Ferrer, F. J., Lin, A., Rhee, M. K., Mah, F. S. (2018). Dry Eye Syndrome Preferred Practice Pattern®. Ophthalmology. doi:10.1016/j.ophtha.2018.10.023
  • TrueTear Intranasal Tear Neurostimulator (Allergan plc) for Treating Moderate to Severe Dry Eye Syndrome. 2020 Jan 22. Ecri.com
  • TearCare (Sight Sciences, Inc.) for Treating Dry Eye Disease. Health Tech Assessment (Product Brief) March 2020. Ecri.com
  • Jie, Y., Sella, R., Feng, J., Gomez, M. L., & Afshari, N. A. (2019). Evaluation of incomplete blinking as a measurement of dry eye disease. Ocul Surf, 17(3), 440-446. doi:10.1016/j.jtos.2019.05.007
  • Maskin SL, Testa WR. Growth of meibomian gland tissue after intraductal meibomian gland probing in patients with obstructive meibomian gland dysfunction.  Br J Ophthalmol. 2018;102(1):59-68.

 

Policy History:

  • June 2020 - Annual Review, Policy Revised
  • September 2019 - Annual Review, Policy Revised
  • September 2018 - Annual Review, Policy Revised
  • September 2017 - Annual Review, Policy Revised
  • September 2016 - New Policy

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.