BlueCross and BlueShield of Montana Medical Policy/Codes
Eyelid Thermal Pulsation Therapy for Dry Eye Syndrome
Chapter: Vision
Current Effective Date: November 26, 2013
Original Effective Date: November 26, 2013
Publish Date: August 26, 2013
Description

Dry eye syndrome, dry eye disease (DED) 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. (1) DED is considered a significant public health problem and is estimated to affect between 14% and 33% of the population worldwide. (2, 3) The prevalence of DED increases with age, especially in postmenopausal women. (2, 3) It is estimated that DED affects more than 7 million Americans older than 40 years of age, (2) and approximately 1 million to 4 million Americans between 65 to 84 years of age. (1) The prevention and treatment of DED is expected to be of greater importance as the population ages.

DED is often classified into either the aqueous-deficient subtype or the evaporative subtype. (2, 3) Although the initial classification of the DED may be either of these, the classification is not mutually exclusive. (2, 3) Meibomian gland dysfunction (MGD), characterized by changes in gland secretion with or without concomitant gland obstruction, is recognized to be the most common cause of evaporative dry eye and may also play a role in aqueous-deficient dry eye. (3, 4)

Current treatment options for MGD include physical expression to relieve the obstruction, administration of heat (warm compresses) to the eyelids to potentially liquefy solidified meibomian gland (MG) contents, eyelid scrubs to relieve external meibomian gland orifice blockage, and medications (e.g., antibiotics, topical corticosteroids) to mitigate infection and inflammation of the eyelids. (4, 5) These treatment options however have shown limited clinical efficacy. (5) Physical expression, for example, can be very painful given the significant amount of force needed to express obstructed glands. Warm compress therapy can be both time-consuming and labor intensive, and there is limited evidence that medications can relieve MGD. (5) While the symptoms of DED often improve with treatment, the disease usually is not curable and may lead to substantial patient and physician frustration. (1) Dry eyes can be a cause of visual morbidity and may compromise results of corneal, cataract, and refractive surgery. Inadequate treatment of DED may result in increased ocular discomfort, blurred vision, reduced quality of life, and decreased productivity. (2) DED is a multi-factorial disease of the ocular surface that may require a combination approach to treatment. (2)

LipiFlow

The LipiFlow Thermal Pulsation System (TearScience Inc., Morrisville, NC) is a new device developed to address the limitations of current treatment options to relieve MGD. (6, 7) This device is designed to safely heat the palpebral surfaces of both the upper and lower eyelids, while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces. This therapeutic device massages the outer eyelids from the base of the meibomian glands in the direction of the gland orifices, thereby expressing the meibomian glands during heating. The LipiFlow® System is composed of 2 primary components, an ocular component (The Disposable) and a handheld control system. The Disposable has 2 parts, a lid warmer and an eyecup. (6, 7)

LipiView

The LipiView Interferometer is an ophthalmic imaging device considered the diagnostic half of the LipiFlow treatment system for meibomian gland dysfunction. The idea is to use LipiView to determine the extent of MGD and then employ the LipiFlow device to treat it. The LipiView device is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the device measures the absolute thickness of the tear film lipid layer.

Regulatory Status

The LipiFlow System (assigned the generic name of eyelid thermal pulsation system) was cleared by the Food and Drug Administration (FDA) in June 2011. (8) The FDA classified the LipiFlow® System into class II (special controls) in order to provide a “reasonable assurance of safety and effectiveness” of the device. (8) The LipiFlow® System is identified by the FDA “as an electrically powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used 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.” (8)

The LipiView is also a class II device cleared by the Food and Drug Administration (FDA) in December 2012.  LipiView Ocular Surface Interferometer with software version 2.0 has the same intended use and the same fundamental scientific technology as a predicate device.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers eyelid thermal pulsation therapy (which may include the use of the LipiView® for diagnosis and/or the LipiFlow® for treatment) experimental, investigational and unproven for all indications including but not limited to dry eye syndrome.

Rationale

This policy was created in August 2013 with a search of the MEDLINE database conducted through May 2013. Following is a summary of the key literature.

Five publications were identified on the LipiFlow System for treatment of meibomian gland dysfunction (MGD). The initial publication of this device by Korb and Blackie, based on findings of a case report on meibomian gland assessment following treatment in a 39-year old Caucasian woman, reported outcomes at 3 months of follow-up; (9) a second publication by the same group of investigators on this patient reported findings at 7 months of follow-up. (10) Funding for these publications was provided by the manufacturer of the device (TearScience Inc., Morrisville, NC). The third publication (also manufacturer-funded) by Freidland and colleagues was a feasibility study reporting on findings from 14 adult patients treated with this device for obstructive MGD. (11)

The remaining two publications were based on the results of a randomized clinical trial of this device for the treatment of MGD. The primary analysis by Lane and colleagues reported outcomes up to 1-month follow-up, (6) and a follow-up analysis by Griener reported outcomes at 9 months of follow-up in a sub-cohort of patients. (7) The primary analysis was a prospective, open-label, randomized, crossover multi-center clinical trial undertaken to evaluate the safety and effectiveness of the LipiFlow® System compared to a standardized form of warm compress therapy (iHeat Warm Compress (WC) System, Advanced Vision Research, Woburn, MA) for adults with MGD. (6) As with previous reports, this randomized clinical trial by Lane and colleagues was funded by TearScience Inc. (Morrisville, NC), the manufacturer of the LipiFlow® System. (6)

In the randomized clinical trial (RCT) by Lane and colleagues, 139 adult patients from 9 participating sites (8 U.S. sites, and 1 site in India) were randomized to either the LipiFlow® System (n=69) or WC control (n=70). (6) These patients had reported dry eye symptoms in the past 3 months, had a Standard Patient Evaluation for Eye Dryness (SPEED) score of 6 or greater, and had evidence of meibomian gland obstruction on ophthalmologic examination. Subjects in the LipiFlow® group received a single 12-minute LipiFlow® treatment and were reexamined at day one, 2 weeks and at 4 weeks of follow-up. Patients in the control group received a single 5-minute iHeat® warm compress treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, the control patients crossed over (LipiFlow® Crossover) and received the LipiFlow® treatment. The primary outcome measures were MG assessments performed using a hand-held Meibomian Gland Evaluator. Each of 15 glands was scored on a 0-3 rating scale, resulting in a numerical score from 0-45. The second primary outcome measure was tear break-up time (TBUT) in seconds, measured by the Dry Eye Test Method. Secondary outcome measures included dry eye symptoms measured by 2 standardized instruments, the SPEED score, and the Ocular Surface Disease Index (OSDI). Device-related adverse events were also reported, primarily treatment-related pain and discomfort. The main analyses were performed on a per-protocol basis, and not by intention to treat.

The primary comparison of treatment outcomes was performed at 2 weeks following treatment. At this time point, there were significantly greater improvements for the LipiFlow group on all of the primary and secondary outcome measures. (6) For the MG assessment, there was an improvement of 7.9 points in the LipiFlow® group compared to 0.5 points in the WC group (p<0.0001). The mean change in TBUT was 1.5 seconds in the LipiFlow® group versus 0.1 seconds in the WC group (p=0.0017). For the dry eye symptoms, there was improvement for the LipiFlow® group of 6.2 points on the SPEED scale and 14.7 points on the OSDI scale, compared to changes in the WC group of 3.5 points on the SPEED scale (p<0.0001) and 8.1 points on the OSDI scale (p=0.0004). The percent of patients with at least a 50% improvement in symptoms was 43% in the LipiFlow group versus 11% in the WC group (p value NR). There was no difference in patients-reported pain or discomfort between treatments.

In a follow-up analysis of this trial by Greiner, this improvement in both MG secretion and TBUT was maintained at 9 months in a sub-cohort of 21 adult patients participating in a U.S. single-site. However, this follow-up analysis did not include a control group, and so there were only single-arm results available for patients treated with LipiFlow®. (7)

This RCT indicates that one treatment with LipiFlow® may result in greater short-term improvement in MG dysfunction and dry eye symptoms compared to WC. Limitations of the trial include the short-term time period (2 weeks) for the primary comparative outcomes, and the lack of analysis by intention to treat. The clinical significance of the outcome measures was not assessed, particularly the minimal important clinical difference on the symptom scales. In addition, the comparator used, warm compresses as one relevant alternative treatment, but other modalities such as manual MG expression are also available. The durability of the treatment effect is not defined because the follow-up data did not include treatment with control.

Ongoing Clinical Trials

Three studies on the LipiFlow System for treatment of MGD currently are listed at online site ClinicalTrials.gov. (13, 14, 15)

Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye (NCT01521507)

This is a post-market prospective clinical trial sponsored by the manufacturer (TearScience Inc., Morrisville, NC) of the LipiFlow® System. This trial has the estimated enrollment of 200 adult patients across 8 U.S. sites. This trial is divided into 2 stages. The first stage from enrollment to 3 months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene control therapy with crossover LipiFlow® treatment of the control subjects at 3 months. The second stage, occurring between 3 months and 1 year, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a follow-up period of 1 year. Patients will be entered into pre-specified subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment. The primary outcome measure is the mean change in total MG score between baseline to 3 months, baseline to 6 months, and baseline to 1 year of follow-up, respectively. This study is ongoing but not recruiting participants with the estimated completion date of November 2013.

Comparison of LipiFlow Treatment and a Standard Lid Hygiene Regime (NCT01769105)

This is a randomized prospective single-blind trial comparing the LipiFlow® System with a standard lid hygiene regimen for treatment of MGD. This trial, with an estimated enrollment of 40 adult patients, is being undertaken at a university center in Germany (study sponsor). The primary outcome measure is improvement of dry eye symptoms using standardized questionnaires at 3-month follow-up. This study is currently recruiting participants with the estimated completion date of April 2013.

Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction (NCT01683318)

This is an observational study designed to test the efficacy of the LipiFlow® System for treatment of MGD. This study, with an estimated enrollment of 25 adult patients, is being undertaken at the Singapore National Eye Center (study sponsor). Patients will be asked to undergo a one-time treatment with LipiFlow® and the investigators will assess for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands up to 3 month follow-up. Additionally, dry eye symptoms will be documented in the form of questionnaires. The study investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If the LipiFlow® System of managing MGD is found to be efficacious and safe, it will be made available to eligible patients in Singapore. This study is currently recruiting participants with the estimated completion date of October 2013.

LipiView

A clinical study is underway to determine if the LipiView can provide a statistically reliable estimate of lipid layer thickness as well as tear film thickness. (12)  The following study is listed online at ClinicalTrials.gov:

Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty (NCT01787942) (16)

This study is investigating if there are significant differences in lipid layer thickness (LLT) and other objective dry eye parameters in two situations: 1) patients considering blepharoplasty as compared to other patients not considering such procedures 2) patients before and after undergoing blepharoplasty. The results of these investigations can go towards establishing LLT as an important objective parameter to account for before and after blepharoplasty. Estimated study completion date: December 2013.

Summary

Further prospective RCTs are needed to assess the impact on health outcomes of the LipiView and the LipiFlow System compared to alternative options. These trials will require longer follow-up to assess durability of effect and to accurately predict the optimal frequency of treatment with the LipiFlow® System for individual patients. Based on review of the evidence to date the use of the LipiView and the LipiFlow® Thermal Pulsation System are considered experimental, investigational and unproven for dry eye disease (DED).

Practice Guidelines and Position Statements

In October 2011, the American Academy of Ophthalmology (AAO) developed a Preferred Practice Patterns Guidelines on DED. (1) In the process of developing these guidelines, an updated literature search of articles in the English language was conducted in February 2011 on the subject of dry eye, limited to English language and publication date from 2002 to the date of the search (which was prior to device approval by the FDA). The results were reviewed by the AAO Cornea/External Disease Panel and used to prepare the recommendations for these guidelines.(1) The LipiFlow System was not mentioned as a therapeutic option under their treatment recommendations for DED by disease severity level.(1)

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
375.15, 373.00, 373.12
ICD-10 Codes

H04.121-H04.129

Procedural Codes: 0207T, 0330T
References
  1. American Academy of Ophthalmology. Dry Eye Syndrome Preferred Practice Pattern Guidelines - Limited Edition - October 2011. Available online at: http://one.aao.org . Last Accessed January 2013.
  2. Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care 2011; 17 Suppl 16:S432-9.
  3. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf 2007; 5(2):75-92.
  4. Nichols KK, Foulks GN, Bron AJ et al. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci 2011; 52(4):1922-9.
  5. Blackie CA, Korb DR, Knop E et al. Nonobvious obstructive meibomian gland dysfunction. Cornea 2010; 29(12):1333-45.
  6. Lane SS, DuBiner HB, Epstein RJ et al. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction. Cornea 2012; 31(4):396-404.
  7. Greiner JV. A single LipiFlow® Thermal Pulsation System treatment improves meibomian gland function and reduces dry eye symptoms for 9 months. Curr Eye Res 2012; 37(4):272-8.
  8. Medical devices; ophthalmic devices; classification of the eyelid thermal pulsation system. Final rule. Fed Regist 2011; 76(161):51876-8.
  9. Korb DR, Blackie CA. Restoration of meibomian gland functionality with novel thermodynamic treatment device-a case report. Cornea 2010; 29(8):930-3.
  10. Korb DR, Blackie CA. Case Report: A Successful LipiFlow Treatment of a Single Case of Meibomian Gland Dysfunction and Dropout. Eye Contact Lens 2012.
  11. Friedland BR, Fleming CP, Blackie CA et al. A novel thermodynamic treatment for meibomian gland dysfunction. Curr Eye Res 2011; 36(2):79-87.
  12. Korb DR et al (eds): The Tear Film: Structure, Function and Clinical Examination. Butterworth-Heinemann, 126-92, 2002.
  13. Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye - NCT01521507. Clinicaltrials.gov. Last accessed on 6/2013. www.Clinicaltrials.gov . Last accessed on  June 2013.
  14. Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction NCT01683318.
  15. Comparison of LipiFlow® Treatment and a Standard Lid Hygiene Regime - NCT01769105. Clinicaltrials.gov. Last accessed on  June 2013.
  16. Investigating Abnormal Lipid Layer Thickness and Other Objective Dry Eye Parameters in Patients Seeking Blepharoplasty, and How They Change After Blepharoplasty. NCT01787942. www.Clinicaltrials.gov . Last accessed on  June 2013.
  17. Eyelid Thermal Pulsation for the Treatment of Dry Eye Syndrome. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (February 2013) Other/Vision 9.03.29.
History
August 2013  New 2013 BCBSMT medical policy.  Eyelid thermal pulsation therapy (which may include the use of the LipiView® for diagnosis and/or the LipiFlow® for treatment) is considered experimental, investigational and unproven for all indications including but not limited to dry eye syndrome.
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Eyelid Thermal Pulsation Therapy for Dry Eye Syndrome