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The 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. DED is 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. DED is a multifactorial disease of the ocular surface that may require a combination approach to treatment. 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 role in 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.
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.”
Eyelid thermal pulsation therapy to treat dry eye syndrome is considered investigational.
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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
Blue Cross and Blue Shield Association Policy # 9.03.29
This may not be a comprehensive list of procedure codes applicable to this policy.