Medical Policy: 08.01.24 

Original Effective Date: September 2016 

Reviewed: September 2017 

Revised:  

 

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.

 

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.

 

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

 

In October 2013, the American Academy of Ophthalmology Cornea/External Disease Panel published its preferred practice patterns guidelines on dry eye syndrome. A number of treatment options were recommended. The use of thermal pulsation treatment devices is not mentioned.

 

Prior Approval:

 

Not applicable

 

Policy:

Eyelid thermal pulsation therapy (e.g. Lipiflow®) 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.

 

The trials of Lipiflow do not provide strong evidence of efficacy. The only RCT showing positive findings for most outcomes only followed patients for minimal time. The nonrandomized study showed similar outcomes between eyelid thermal pulsation and standard treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

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.

 

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

 

Policy History:

  • September 2017 - Annual Review, Policy Renewed
  • 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.