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DESCRIPTIONThe 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. DEDis considered a significant public health problem and is estimated to affect between 14% and 33% of the population worldwide. The prevalence of DED increases with age, especially in postmenopausal women. It is estimated that DED affects more than 7 million Americans older than 40 years of age, and approximately 1 million to 4 million Americans between 65 to 84 years of age. 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. Although the initial classification of the DED may be either of these, the classification is not mutually exclusive. 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 rolein aqueous-deficient dry eye.
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. These treatment options however have shown limited clinical efficacy. 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 DED 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 DED may result in increased ocular discomfort, blurred vision, reduced quality of life, and decreased productivity. DED is a multi-factorial disease of the ocular surface that may require a combination approach to treatment.
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. 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.
The LipiFlow® System (assigned the generic name of eyelid thermal pulsation system) was cleared by the Food and Drug Administration (FDA) in June 2011. 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. 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.”
POLICYEyelid thermal pulsation therapy to treat dry eye syndrome is considered investigational.
POLICY EXCEPTIONSFederal 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 GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/18/2013: Approved by Medical Policy Advisory Committee.
SOURCE(S)Blue Cross and Blue Shield Association Policy # 9.03.29
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.