Latest Review Date: April 2025

Category: Vision                                                               

POLICY:

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 the most common cause of dry eye syndrome.

In a 2022 meta-analysis of three United States studies, the prevalence of dry eye ranged from 5% to 14% with an estimated pooled prevalence of 8%. The prevalence of MGD ranged from 10% to 55%. Over a 5-year period, the incidence of dry eye was 3% among individuals aged 18 and older, and 8% among those aged 68 and older.  Prevention and treatment of dry eye syndrome are expected to be of greater importance as the population ages.

Treatment

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.

KEY POINTS:

The most recent literature update was performed through February 12, 2025.

Summary of Evidence

For individuals who have dry eye symptoms consistent with meibomian gland dysfunction (MGD) who receive eyelid thermal pulsation, the evidence includes systematic reviews, randomized controlled trials (RCTs), and observational studies. Relevant outcomes are symptoms, morbid events, and functional outcomes. A 2024 Cochrane meta-analysis evaluated the LipiFlow system's efficacy and safety for dry eye disease through 13 randomized controlled trials (RCTs) with 1155 participants. The findings showed that LipiFlow was comparable to other treatments like warm compresses, thermostatic devices, prescription eye drops, and doxycycline, with no notable differences in symptoms or signs. However, the evidence was deemed of low to very low certainty due to a high risk of bias. Similarly, another systematic review commissioned by the American Academy of Ophthalmology revealed that thermal pulsation with LipiFlow was more effective for meibomian gland dysfunction (MGD) and dry eye than conventional therapies such as warm compresses or eyelid hygiene. However, the review also highlighted some limitations, particularly concerning the treatment's long-term durability. Since the publication of systematic reviews, two industry[1]sponsored RCTs examining eyelid thermal pulsation for dry eye syndrome have been published. A randomized, assessor[1]masked trial comparing the efficacy and safety of LipiFlow versus thermo-mechanical action was conducted in participants with MGD across five US centers. The study involved 106 participants with primary efficacy outcomes assessed at baseline, 4 weeks, and 12 weeks post-treatment. Results showed significant TBUT improvements in both groups, with thermo-mechanical action proving non-inferior to LipiFlow , and no device-related adverse events were reported. A second randomized, assessor-masked controlled superiority trial was conducted to compare the TearCare thermal pulsation system with topical cyclosporine 0.05% (CsA) in 345 participants across 19 clinics in 11 US states. The trial found significant TBUT improvements in both groups, with TearCare showing greater enhancement, and notable OSDI improvements without significant differences between treatments. Both therapies were safe, with mild to moderate treatment-related adverse events occurring in a small proportion of participants. Observational studies on LipiFlow have shown sustained treatment effects for most outcomes up to 3 years. Additional RCTs are needed before any definitive conclusions can be drawn about the comparative benefits and risks of eyelid thermal pulsation therapy. These trials should include adequate masking, standardized testing methodologies, and longer follow-up periods. This will help ensure that the results are reliable and applicable to a broader population. The evidence is insufficient to determine that technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

In 2018, the American Academy of Ophthalmology (AAO) 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 AAO 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 the efficacy of these costly, primarily fee-for-service treatments."

In 2023, the American Academy of Ophthalmology (AAO) updated preferred practice pattern guidelines on dry eye syndrome. These guidelines list thermal pulsation devices as a second-stage option for treatment of dry eye disease. 

 In 2023, the AAO updated preferred practice pattern guidelines for blepharitis.  These guidelines indicate that multiple industry[1]sponsored studies have demonstrated that a single vectored thermal pulsation (VTP) treatment can be effective at improving meibomian gland function and reducing dry eye symptoms for a year or more post procedure. However, there have been no independent RCTs confirming or refuting these industry-sponsored studies.

"There are several in-office procedural treatments available that may improve the inspissated meibomian gland orifices using intense pulsed light (IPL) or theoretically unclog the meibomian glands by mechanical means (e.g., microblepharoexfoliation of the eyelid margin, meibomian gland probing, and/or devices using thermal pulsation). Although there has been industry[1]sponsored studies, independent, randomized clinical trials have yet to be performed to assess efficacy or superiority of any one of these treatments over another. [moderate quality, discretionary recommendation]"

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

LipiFlow®, Dry eye, Dry eye syndrome, Meibomian gland dysfunction, LipiFlow® Thermal Pulsation System, iLux® System, Systane® iLux2®, TearCare® System, TearCare® MGX™, Tixel i

APPROVED BY GOVERNING BODIES:

Eyelid thermal pulsation systems (FDA product code: ORZ) cleared by the U.S. Food and Drug Administration (FDA) are summarized in Table 1.

Table 1. Eyelid Thermal Pulsation Systems Cleared by the FDA

*Other 501(k) numbers are associated with more recent versions of the device.

* Alcon, a division of Novartis, acquired Tear Film Innovations in 2018.

BENEFIT APPLICATION:

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. 

CURRENT CODING:

CPT Codes:

REFERENCES:

1. Amescua G, Ahmad S, Cheung AY, et al. Dry Eye Syndrome Preferred Practice Pattern®. Ophthalmology. Apr 2024; 131(4): P1-P49.
2. Ayres BD, Bloomenstein MR, Loh J, et al. A Randomized, Controlled Trial Comparing Tearcare ® and Cyclosporine Ophthalmic Emulsion for the Treatment of Dry Eye Disease (SAHARA). Clin Ophthalmol. 2023; 17: 3925-3940.
3. 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.
4. Blackie CA, Korb DR, Knop E et al. Nonobvious obstructive meibomian gland dysfunction. Cornea 2010; 29(12):1333-45.
5. Blepharitis. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. San Francisco, CA: American Academy of Ophthalmology; 2018.
6. Dry Eye Syndrome. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern Guidelines. San Francisco, CA: American Academy of Ophthalmology; 2018.
7. 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.
8. 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.
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.
10. Food and Drug Administration. 510(k) Premarket www.accessdata.fda.gov/cdrh_docs/pdf24/K240512.pdf. 
11. 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.
12. 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.
13. 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.
14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
15. 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.
16. Lin A, Ahmad S, Amescua G, et al. Blepharitis Preferred Practice Pattern®. Ophthalmology. Apr 2024; 131(4): P50-P86.
17. McCann P, Abraham AG, Mukhopadhyay A, et al. Prevalence and Incidence of Dry Eye and Meibomian Gland Dysfunction in the United States: A Systematic Review and Meta-analysis. JAMA Ophthalmol. Dec 01 2022; 140(12): 1181-1192.
18. Matossian C, Chang DH, Whitman J, et al. Preoperative Treatment of Meibomian Gland Dysfunction with a VectoredThermal Pulsation System Prior to Extended Depth of Focus IOL Implantation. Ophthalmol Ther. Oct 2023; 12(5): 2427-2439.
19. Mencucci R, Mercuri S, Cennamo M, et al. Efficacy of vector thermal pulsation treatment in reducing postcataract surgerydry eye disease in patients affected by meibomian gland dysfunction. J Cataract Refract Surg. Apr 01 2023; 49(4): 423-429.
20. Meng Z, Chu X, Zhang C, et al. Efficacy and Safety evaluation of a single thermal pulsation system treatment (Lipiflow ® )on meibomian gland dysfunction: a randomized controlled clinical trial. Int Ophthalmol. Apr 2023; 43(4): 1175-1184
21. 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.
22. Pucker AD, Yim TW, Rueff E, et al. LipiFlow for the treatment of dry eye disease. Cochrane Database Syst Rev. Feb 05 2024; 2(2): CD015448.
23. Sadri E, Verachtert A, Parkhurst GD, et al. Effectiveness and safety of a thermo-mechanical action device versus thermal pulsation device in the treatment of meibomian gland dysfunction. J Cataract Refract Surg. Dec 16 2024.
24. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II Epidemiology Report. Ocul Surf. Jul 2017; 15(3): 334-365.
25. Tao JP, Shen JF, Aakalu VK, et al. Thermal Pulsation in the Management of Meibomian Gland Dysfunction and Dry Eye: AReport by the American Academy of Ophthalmology. Ophthalmology. Dec 2023; 130(12): 1336-1341.
26. 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.
27. 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.

POLICY HISTORY:

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.

Medical Policy Panel, March 2023

Medical Policy Group, March 2023 (9): Updates to Key Points. No change to policy statement.

Medical Policy Panel, March 2024

Medical Policy Group, April 2024 (9): Updates to Key Points, Key Words: LipiFlow® Thermal Pulsation System, iLux® System, Systane® iLux2®, TearCare® System, TearCare® MGX™, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, March 2025

Medical Policy Group, April 2025 (9): Updates to Description, Key Points, Key Words: Tixel i, Approved by Governing Bodies and References.

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.