Eyelid Thermal Pulsation for the Treatment of Dry Eye Syndrome

POLICY NUMBER

A.9.03.29

DESCRIPTION

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

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 5% and 50% 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 3 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. 

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 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. For example, physical expression can be very painful given the amount of force needed to express obstructed glands. Warm compress therapy can be time-consuming and labor intensive, and there is limited evidence that medications relieve meibomian gland dysfunction. 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.

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

Eyelid Thermal Pulsation Systems Cleared by the FDA

*Other 510(k) numbers are associated with more recent versions of the device.aAlcon, a division of Novartis, acquired Tear Film Innovations in 2018.

POLICY

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

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/18/2013: Approved by Medical Policy Advisory Committee.

04/28/2014: Policy reviewed; no changes.

05/14/2015: Policy reviewed. Policy description and statement unchanged. Policy guidelines updated to revise investigational definition.

07/20/2015: Code Reference section updated for ICD-10.

04/25/2016: Policy description updated regarding devices. Policy statement unchanged.

05/27/2016: Policy number A.9.03.29 added.

04/03/2017: Policy title updated to add "Syndrome." Policy description updated. Policy statement unchanged.

04/16/2018: Policy reviewed; no changes.

04/11/2019: Policy description updated to remove information regarding classification of dry eye syndrome and devices. Policy statement unchanged.

12/20/2019: Code Reference section updated to add new CPT code 0563T effective 01/01/2020.

04/20/2020: Policy reviewed; no changes.

06/10/2021: Policy description updated regarding data for dry eye syndrome and devices. Policy statement unchanged.

05/23/2022: Policy description updated regarding devices. Policy statement unchanged.

04/21/2023: Policy reviewed; no changes.

04/25/2024: Policy description updated regarding devices. Policy statement unchanged.

04/23/2025: Policy description updated regarding dry eye syndrome. Policy statement unchanged.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 9.03.29

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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