mp-522 - Medical Policies - Alabama
Eyelid Thermal Pulsation for the Treatment of Dry Eye Syndrome
Policy Number: MP-522
Latest Review Date: March 2022
Eyelid thermal pulsation for the treatment of dry eye syndrome is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Thermal pulsation is a treatment option for meibomian gland dysfunction. Meibomian gland dysfunction is recognized as the major cause of dry eye syndrome. Thermal pulsation applies heat 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 (DES)
Dry eye syndrome, 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. It is estimated to affect between five percent and fifty percent of the population worldwide. Based on data from 2013, an estimated 16.4 million Americans have dry eye syndrome. The prevalence of dry eye syndrome increases with age, especially in postmenopausal women. For both sexes, prevalence is more than three times higher in individuals 50 years of age or older compared to those 18 to 49 years of age. Meibomian gland dysfunction (MGD) is considered to be the most common cause of dry eye syndrome. Prevention and treatment of dry eye syndrome are expected to be of greater importance as the population ages.
Current treatment options for Meibomian gland dysfunction include physical expression to relieve the obstruction, administration of heat (warm compresses) to the eyelids to potentially liquefy solidified meibomian gland 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. These treatment options however have shown limited clinical efficacy and often require a trial-and-error approach. 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. While the symptoms of dry eye syndrome 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 dry eye syndrome may result in increased ocular discomfort, blurred vision, reduced quality of life, and decreased productivity.
The most recent literature update was performed through December 20, 2021.
Summary of Evidence
For individuals who have dry eye symptoms consistent with MGD who receive eyelid thermal pulsation, the evidence includes four RCTs, a nonrandomized comparison study, and longer term follow-up of patients from RCTs and observational studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. The trials do not provide strong evidence of long-term efficacy. Two RCTs have demonstrated positive findings for most outcome measures over the short term (up to three months). Observational studies have shown sustained treatment effects for most outcomes up to three years. The nonrandomized study showed similar outcomes for eyelid thermal pulsation and standard treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Practice Guidelines and Position Statements
The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.
American Academy of Ophthalmology
In 2018, the American Academy of Ophthalmology updated preferred practice patterns guidelines on dry eye syndrome. These guidelines list "In-office, physical heating and expression of the meibomian glands (including device-assisted therapies, such as LipiFlow, or intense pulse light treatment)" as one of several step-up treatments for patients who do not respond to conventional management, including the elimination of environmental factors and offending medications, dietary modifications, ocular lubricants, and lid hygiene and warm compresses.
In 2018, the American Academy of Ophthalmology updated preferred practice patterns guidelines on blepharitis. These guidelines cover the three clinical subcategories of blepharitis: staphylococcal, seborrheic, and meibomian gland dysfunction (posterior blepharitis specifically affects the meibomian glands). The following statements are made relevant to thermal pulsation treatment:
"There are also several in-office procedural treatments available that may theoretically unclog the inspissated meibomian gland orifices using intense pulsed light (IPL) or mechanical means (e.g., microblepharoexfoliation of the eyelid margin, meibomian gland probing, and/or devices using thermal pulsation). Although there have been industry-sponsored studies, independent, randomized, masked clinical trials have yet to be performed to assess efficacy of these costly, primarily fee-for-service treatments."
U.S. Preventive Services Task Force Recommendations
LipiFlow®, Dry eye, Dry eye syndrome, Meibomian gland dysfunction
APPROVED BY GOVERNING BODIES:
In 2011, the LipiFlow® Thermal Pulsation System (TearScience; assigned the generic name of eyelid thermal pulsation system) was cleared by the U.S. Food and Drug Administration (FDA). In 2017 and 2020, two eyelid thermal pulsation systems (iLux® System and Systane® iLux2®, respectively) were also cleared by the FDA. The FDA classified these devices as class II (special controls) to provide a “reasonable assurance of safety and effectiveness” of the device. All three devices were identified by FDA as a "Battery-operated, handheld device that the physician uses in an in-office procedure to control the application of warmth and massage to the eyelids. The handheld device connects to a single-use disposable unit made of biocompatible polycarbonate and silicone that is inserted around the patient's eyelids. The device provides controlled warmth to the inner eyelid surface, close to the location of the meibomian glands, and intermittent massage to the outer eyelid surface to facilitate release of lipid from the cystic meibomian glands." All three devices are indicated for "the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye." The Systane® iLux2® system is also indicated "to capture/store digital images and video of the meibomian glands."
Additionally FDA-cleared eyelid thermal pulsation systems include, but are not limited to, the TearCare® System (Sight Sciences, Inc., K213045, December 2021). The TearCare® System is indicated for "the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to Meibomian Gland Dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands."
FDA product code: ORZ.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
Tear film imaging, unilateral or bilateral, with interpretation and report
(e.g., LipiView Ocular Surface Interferometer, which is being marketed for use with eyelid thermal pulsation treatment)
Near-infrared dual imaging (i.e. simultaneous reflective and trans-illuminated light) of meibomian glands, unilateral or bilateral, with interpretation and report: This service may be used in conjunction with the LipiScan Thermal Pulsation System.
Evacuation of Meibomian glands, using heat delivered through wearable, open-eye eyelid treatment devices and manual gland expression, bilateral
- 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.
- Blackie CA, Korb DR, Knop E et al. Nonobvious obstructive meibomian gland dysfunction. Cornea 2010; 29(12):1333-45.
- Blepharitis. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. San Francisco, CA: American Academy of Ophthalmology; 2018.
- Dry Eye Syndrome. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. San Francisco, CA: American Academy of Ophthalmology; 2018.
- Farrand KF, Fridman M, Stillman IO, et al. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. Oct 2017; 182: 90-98.
- 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. Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care 2011; 17 Suppl 16:S432-9.
- Finis D, Konig C, Hayajneh J, et al. Six-month effects of a thermodynamic treatment for MGD and implications of meibomian gland atrophy. Cornea. Dec 2014; 33(12):1265-1270.
- Food and Drug Administration. 510(k) Premarket Notification.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112704; Accessed February 25, 2022
- Greiner JV. Long-term (12-month) improvement in meibomian gland function and reduced dry eye symptoms with a single thermal pulsation treatment. Clin Experiment Ophthalmol 2013; 41(6):524-30.
- 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.
- Hura AS, Epitropoulos AT, Czyz CN, et al. Visible Meibomian Gland Structure Increases After Vectored Thermal Pulsation Treatment in Dry Eye Disease Patients with Meibomian Gland Dysfunction. Clin Ophthalmol. 2020; 14: 4287-4296.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- 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.
- Miller KL, Walt JG, Mink DR et al. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol 2010; 128(1):94-101.
- Ngo W, Situ P, Keir N et al. Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire. Cornea 2013; 32(9):1204-10.
- 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.
- Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II Epidemiology Report. Ocul Surf. Jul 2017; 15(3): 334-365.
- Tauber J. A 6-Week, Prospective, Randomized, Single-Masked Study of Lifitegrast Ophthalmic Solution 5% Versus Thermal Pulsation Procedure for Treatment of Inflammatory Meibomian Gland Dysfunction. Cornea. Apr 2020; 39(4): 403-407.
- Zhao Y, Veerappan A, Yeo S, et al. Clinical Trial of Thermal Pulsation (LipiFlow) in Meibomian Gland Dysfunction With Preteatment Meibography. Eye Contact Lens. Nov 2016; 42(6): 339-346.
Medical Policy Panel, February 2013
Medical Policy Group, February 2013 (3): New policy adopted; investigational per policy statement
Medical Policy Administration Committee, March 2013
Available for comment March 12 through April 25, 2013
Medical Policy Panel, March 2014
Medical Policy Group, March 2014 (1): Update to Key Points and References; no change to policy statement
Medical Policy Panel, March 2015
Medical Policy Group, March 2015 (6): Updates to Description, Key Points and References; no change to policy statement.
Medical Policy Panel, March 2016
Medical Policy Group, March 2016 (6): Updates to Key Points and References; no change to policy statement.
Medical Policy Panel, March 2017
Medical Policy Group, March 2017 (6): Updates to Description, Key Points and References; no change to policy statement.
Medical Policy Panel, March 2018
Medical Policy Group, March 2018 (6): Updates to Description and Key Points.
Medical Policy Panel, March 2019
Medical Policy Group, March 2019 (6): Updates to Description and Key Points. No change to policy statement.
Medical Policy Group, December 2019 (6): 2020 Annual Coding Update added 0563T.
Medical Policy Panel, March 2020
Medical Policy Group, March 2020 (6): Updates to Key Points and Coding (0507T).
Medical Policy Panel, March 2021
Medical Policy Group, March 2021 (9): 2021 Updates to Key Points, Description, Approved By Governing Bodies, References. Policy statement updated to remove “not medically necessary,” no change to policy intent.
Medical Policy Panel, March 2022
Medical Policy Group, March 2022 (9): 2022 Updates to Key Points, Description, References. No change to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.