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MP 9.03.29  Eyelid Thermal Pulsation for the Treatment of Dry Eye Syndrome

Medical Policy    
Section
Miscellaneous Policies
 
Original Policy Date
February 2013
Last Review Status/Date
Created with literature search/2:2013
Issue
2:2013
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Description

The LipiFlow® Thermal Pulsation System (TearScience Inc., Morrisville, NC) is a new treatment option for addressing meibomian gland dysfunction (MGD). MGD is recognized as the major cause of dry eye syndrome. The LipiFlow® System allows heat to be applied to the palpebral surfaces of the upper and lower eyelids directly over the meibomian glands, while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands.

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)

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. The 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)

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)


Policy

Eyelid thermal pulsation therapy to treat dry eye syndrome is considered investigational.


Policy Guidelines

There is a CPT category III code specific to this treatment –

0207T: Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral.

Effective in July 2013, there is a CPT category III code for tear film imaging (e.g., LipiView Ocular Surface Interferometer), which is being marketed for use with this treatment –

0330T: Tear film imaging, unilateral or bilateral, with interpretation and report.


 

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.


Rationale

 

Literature Review

This policy was created in February 2012 with a search of the MEDLINE database through November 7, 2012. 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.

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 enrolment 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.

Summary

The LipiFlow® Thermal Pulsation System (TearScience Inc., Morrisville, NC) is a new treatment option for addressing meibomian gland dysfunction (MGD). The evidence to date on the LipiFlow® System is based on five publications for treatment of MGD, all of which have been funded by the manufacturer of this device. This evidence consists of one case-report (reported in two separate publications at two periods of follow-up), one small case series, and one randomized clinical trial (RCT) with crossover and a follow-up analysis in a sub-cohort of patients.

The RCT reported short-term benefits for LipiFlow® on measures of MG function and dry eye symptoms. However, this single trial is insufficient to determine the effect of LipiFlow® on health outcomes. The comparative results were short term (2 weeks), and the clinical significance of the differences is not clear. Further prospective RCTs are needed to assess the impact on health outcomes of the LipiFlow® System compared to alternative treatment 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 LipiFlow® Thermal Pulsation System is considered investigational 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 theAAO Cornea/External DiseasePanel 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)

Medicare National Coverage

No national coverage determination.

References:

  1. American Academy of Ophthalmology. Dry Eye Syndrome Preferred Practice Pattern Guidelines - Limited Edition - October 2011. Available online at: http://one.aao.org/ce/practiceguidelines/ppp_content.aspx?cid=127dbdce-4271-471a-b6d9-464b9d15b748. 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.  

Codes

Number

Description

CPT  0207T Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
ICD-9 Diagnosis    Investigational for all diagnoses
ICD-10-CM (effective 10/1/14)   Investigational for all diagnoses
  H04.121-H04.129 Dry eye syndrome code range
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.


Index

LipiFlow®
Dry eye
Dry eye syndrome
Meibomian gland dysfunction


Policy History

Date Action Reason
02/14/13 Policy added to Other Policy created with literature search through November 7, 2012; considered investigational.