Medical Policy

 

Subject: Automated Evacuation of Meibomian Gland
Document #: MED.00103 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

This document addresses the use of devices which will automate the process of applying heat and intermittent pressure for the treatment of meibomian gland dysfunction (MGD) and associated imaging.

Position Statement

Investigational and Not Medically Necessary:

The use of an automated evacuation device using heat and intermittent pressure, and associated tear film imaging, is considered investigational and not medically necessary for the treatment of meibomian gland dysfunction.

Rationale

Goto and colleagues (2002) reported on the safety and short-term efficacy of an infrared warm compression device used in 37 subjects with a diagnosis of non-inflamed meibomian gland dysfunction. Subjective symptom scores, face scores, tear evaporation rates, fluorescein and rose bengal vital staining, tear break-up time, Schirmer test, meibomian gland obstruction, and meibography were compared before and after 2 weeks of treatment. Following 2 weeks of treatment, total symptom scores improved from 12.3 to 8.4. Face scores improved from 7.0 to 5.3. Tear evaporation rates did not change significantly after treatment, but evaporation during forced blinking decreased from 22.1 to 16.2. Improvement of scores was also noted in fluorescein and rose bengal vital staining, tear break-up time in seconds, Schirmer test and meibomian gland obstruction. No change was noted in meibography score before and after treatment. The authors concluded that the infrared warm compression device was safe and effective for the meibomian gland dysfunction after 2 weeks of treatment. However, the treatment in this study was limited to non-inflamed meibomian gland dysfunction. The authors have no experience with this treatment for meibomian gland dysfunction with active inflammation. With a small group size and lack of a control group, the authors concluded that a long term study would be required.

In 2006, Matsumoto reported the evaluation of safety and efficacy of a warm moist air device on tear functions and meibomian gland dysfunction. In a short-term study, 15 individuals with simple meibomian gland dysfunction and 20 control individuals were enrolled to evaluate the safety and short-term effects of a warm moist air device. All individuals underwent moist warm air applications for 10 minutes. Visual analog scores were used to measure symptoms of ocular surface fatigue, changes in tear functions and ocular surface status. Tear film break-up time measurements were obtained along with Schirmer test 1, fluorescein staining scores and rose bengal staining scores. After the initial study, another longer-term clinical trial was started. Ten individuals with simple meibomian gland dysfunction received warm moist air treatment for 2 weeks and another 10 individuals with simple meibomian gland dysfunction received warm towel compresses for 2 weeks. Treatment was performed for 10 minutes twice a day for 2 weeks. Visual analog scores, tear film break-up time measurements, fluorescein and rose bengal staining scores were measured before and 24 hours after each treatment. Visual analog scores showed improvement with warm moist air application in the short-term study and in both the warm moist air device and warm compress application groups after 2 weeks. Tear film break-up time improved from 3.9 seconds to 10.9 seconds in the individuals with meibomian gland dysfunction with warm moist air application in the short-term study. The tear film time did not change significantly in the control group. Schirmer test, fluorescein and rose bengal staining scores did not show significant changes with warm moist air application in the short-term study, nor did it change in the warm moist air device or warm compress groups after 2 weeks.

Friedland and colleagues (2011) reported on 14 individuals with a prior diagnosis of meibomian gland dysfunction during an open label, multi-center trial where participants received a 12-minute treatment with an automated device that delivers heat and massage along the eyelids from the terminal ends of the meibomian glands to the meibomian gland orifices. Automated treatment was given to both eyes in succession. There was no control group; however, individuals also received additional expression on one eye only with a handheld instrument which was manipulated against the inner surface of the lower eyelid while the meibomian glands were manually expressed with the thumb or index finger. The purpose of the automated device is to soften the obstruction with heat and express the obstruction with pulsatile pressure. Subjects were evaluated at baseline and following treatment at 1 week, 1 month and 3 months. Individuals were observed for the number of meibomian glands yielding liquid secretion, tear film break-up time, corneal fluorescein staining, dry eye symptoms, and discomfort or pain during the treatment. The mean number of meibomian glands yielding liquid secretion increased from 2.9 at baseline to 9.9 at 3 months. Tear film break-up time on average increased from 5.2 seconds at baseline to 11.0 seconds at 3 months. On average, corneal fluorescein staining decreased from 0.6 seconds to 0.1 seconds at 3 months. Dry eye symptoms were measured using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The SPEED score decreased on average from 16.2 at baseline to 7.8 at 3 months. During the automated treatment, discomfort scores were reported as 2.3-2.4 and they were reported as 3.7 during the handheld device. One individual received only 10.5 minutes of treatment with the automated device as it was stopped due to discomfort.

An industry sponsored, open-label single-crossover, multicenter trial (Lane et al, 2012) compared the LipiFlow (TearScience®, Morrisville, NC) automated office-based device with standardized warm compress using the iHeat (Advanced Vision Research, Woburn, MA) portable warm compress system. The LipiFlow device is designed to relieve obstruction of the meibomian glands with the application of heat and graded pulsatile pressure to the upper and lower eyelids. The study compared the outcomes of 139 subjects with meibomian gland dysfunction randomized to either LipiFlow (treatment group; n=69) or warm compresses (control group; n=70). The LipiFlow group received a 12-minute LipiFlow treatment and was examined at day 1, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat warm compression treatment with instructions to perform the same treatment daily for 2 weeks. After 2 weeks, 68 individuals from the control group (warm compresses) crossed over and then received treatment via the automated LipiFlow device. Primary outcome effectiveness was measured by assessment of meibomian glands (using a handheld instrument) and tear break-up time. Secondary outcomes were measured with the SPEED and Ocular Surface Disease Index (OSDI) questionnaires. After 2 weeks, the individuals receiving the LipiFlow treatment showed an increase from baseline in the metrics of meibomian gland secretion characteristics and increase in tear break-up time. There was no significant change in those measures in the control group. After crossover at 2 weeks, the 68 control subjects who then received the LipiFlow treatment also showed an increase in meibomian gland secretion characteristics. This study did not include a group receiving warm compresses only for 4 weeks. It is notable that although the control group did not show significant increases in meibomian gland and tear film metrics at 2 weeks, the control group did have a significant reduction in self-reported dry eye symptom frequency and severity. Also, the control group was limited to 5 minutes of warm compression therapy once a day, while typical treatment for meibomian gland dysfunction consists of hot packs 3 to 4 times daily along with lid margin scrubs.

A study by Finis and colleagues (2014a) reported on participants who were randomized to receive either a single LipiFlow treatment or a participant-performed twice-daily lid warming and massage for 3 months. Participants were evaluated before treatment and at 1 and 3 months following treatment. A total of 31 participants completed the 3 month follow-up. At 1 and 3 months, the participants in the LipiFlow treatment group had a reduction in OSDI scores compared with those in the lid warming and massage group. Both treatments were found to have a significant improvement in expressible meibomian glands compared to the baseline parameters, but no significant difference was noted between the two groups. While the study showed that a single LipiFlow treatment is at least as effective as a 3 month lid margin hygiene regimen, this study was observer-masked only and a placebo effect may have confounded improvements in subjective symptoms.

Blackie and colleagues (2016) conducted an open-label clinical trial to measure the long-term effectiveness of vectored thermal pulsation (VTP, Lipiflow treatment in improving meibomian gland function and dry eye symptoms in affected participants. In this 12-month study, 200 participants (400 eyes, age range 22-85 years) were randomized into a treatment group (n=101) using a single VT device 2 times daily for 3 months, and a control group (n=99) using conventional warm compress and eyelid hygiene therapy. The authors compared the meibomian gland secretion (MGS) and the mean Ocular Surface Disease Index© (OSDI) score at 12 months between the control and treatment groups. At 3 months, the control group participants crossed over to receive VTP treatments. The effectiveness on MGS and dry eye symptoms was assessed at baseline and at 1, 3, 6, 9, and 12 months. The treatment group had greater mean improvement in MGS (p<0.0001) and dry eye symptoms (p=0.0068) at the 3-month interval compared to the control group. Compared to the control group, at 3 months the treatment group had a greater MGS mean improvement (p<0.0001) and dry eye symptoms (p=0.0068). At 12 months, 86% of the treatment had a sustained MGS mean improvement from 6.4 ± 3.7 at baseline to 17.3 ± 9.1 (p<0.0001) and dry eye symptoms from 44.1 ± 20.4 to 21.6 ± 21.3 (p<0.0001). At 12 months, 89% of the crossover group had a sustained MGS mean improvement from 6.3 ± 3.6 to 18.4 ± 11.1 (p<0.0001) and dry eye symptoms from 49.1 ± 21.0 to 24.0 ± 23.2 (p<0.0001). A greater MGS mean improvement was related to a less severe condition at baseline (p=0.0017) and reduced time between diagnosis and treatment (p=0.0378). The authors concluded that the use of VTP for MGD reduced symptoms and provided prolonged relief. Of note, study subjects were 97% Caucasian, 71% female and the lead authors were affiliated with TearScience, Inc, the manufacturer of Lipiflow.

While initial studies suggest that automated pulse pressure-heat devices appear to be a safe and a promising treatment for meibomian gland dysfunction, further study is needed. Most of the current literature is limited to small group sizes and short follow-up (Finis, 2014b; Greiner, 2012) and there is insufficient published literature comparing the treatment effect of an automated evacuation device to conventional treatment.

Background/Overview

The meibomian glands are oil-secreting glands located within the eyelids. They are located in both the upper and lower eyelids. The ducts for the glands are located along the margin of the eyelid. They discharge an oily secretion known as sebum which lubricates the eyelids. The glands release the oil into tear film. The released oil helps to prevent the water in tears from evaporating. This helps to prevent dry eyes from occurring. If the oil becomes too thick, it can lead to a blockage of the duct which takes the oil from the gland to the tear film. The oil will continue to be made and this can lead to swelling and filling of the gland. A severe blockage can lead to enlarged glands or infection. Lack of oil in the tear film can also lead to dry eyes. An infection may require antibiotics. Conventional treatment includes unclogging the glands which are blocked. This can be accomplished by applying heat (such as a warm compress) to the eyelid and finger massage.

The U.S. Food and Drug Administration (FDA) has granted 510(k) marketing clearance to several devices for use in the application of localized heat and pressure therapy to the eyelids for chronic cystic conditions of the eyelids, including meibomian gland dysfunction. The LipiFlow system is an automated office-based device that 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. The LipiView Ocular Surface Interferometer frequently used with the LipiFlow system, creates images to measure the tear film lipid layer.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

0207T

Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral

0330T

Tear film imaging, unilateral or bilateral, with interpretation and report

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Blackie C, Coleman C, Holland, H. 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.
  2. Finis D, Hayajneh J, König C, et al. Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial. Ocul Surf. 2014a; 12(2):146-154.
  3. Finis D, König C, Hayajneh J, et al. Six-month effects of a thermodynamic treatment for MGD and implications of meibomian gland atrophy. Cornea. 2014b; 33(12):1265-1267.
  4. Friedland BR, Fleming CP, Blackie CA, Korb DR. A novel thermodynamic treatment for meibomian gland dysfunction. Curr Eye Res. 2011; 36(2):79-87.
  5. Goto E, Monden Y, Takano Y, et al. Treatment of non-inflamed obstructive meibomian gland dysfunction by an infrared warm compression device. Br J Ophthalmol. 2002; 86(12):1403-1407.
  6. 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):272-278.
  7. 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.
  8. Matsumoto Y, Dogru M, Goto E, et al. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Cornea. 2006; 25(6):644-650.
  9. Romero JM, Biser SA, Perry HD, et al. Conservative treatment of meibomian gland dysfunction. Eye Contact Lens. 2004; 30(1):14-19.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. LipiFlow® Thermal Pulsation System. No. K093937. Rockville, MD: FDA. June 28, 0211. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093937.pdf. Accessed on September 15, 2017.
  2. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Lipiview® II Ocular Surface Interferometer. No. K152869. Silver Spring MD: FDA. January 14, 2016. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf15/k152869.pdf. Accessed on September 15, 2017.
Websites for Additional Information
  1. National Eye Institute. U.S. National Institutes of Health. Available at: http://www.nei.nih.gov/. Accessed on September 15, 2017.
Index

LipiFlowThermal Pulsation System
Meibomian gland
TearScience
Vectored thermal pulsation (VTP)

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated Rationale section.

Reviewed

11/03/2016

MPTAC review. Updated the Rationale and References sections.

Revised

11/05/2015

MPTAC review. Addition of tear film imaging to Investigational and Not Medically Necessary Statement. Updated Description, Background/Overview and Coding sections. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated Rationale and References sections.

Reviewed

11/14/2013

MPTAC review.

Reviewed

11/08/2012

MPTAC review. Updated Rationale, Background/Overview and References.

Reviewed

11/17/2011

MPTAC review. Updated Rationale, References and Index.

Reviewed

11/18/2010

MPTAC review. Updated Rationale and References.

New

11/19/2009

MPTAC review. Initial document development.