BlueCross BlueShield of Tennessee Medical Policy Manual

Eyelid Thermal Pulsation

DESCRIPTION

Dry eye disease, dry eye syndrome, or dysfunctional tear syndrome are frequent causes of ocular irritation and affects more than 7 million Americans over the age of 40.  Meibomian gland dysfunction (MGD) causes changes in the secretion of the glands with or without orifice obstruction and is recognized as the most common cause of evaporative dry eye disease. MGD may also play a role in aqueous deficient dry eye. Current treatment options for MGD include warm compresses to help liquify the secretions, expression of secretions to relieve an obstruction, eyelid scrubs/hygiene, and medications (e.g. antibiotics, topical corticosteroids).

Thermal pulsation is a new treatment option that has been investigated to treat meibomian gland dysfunction (MGD). Thermal pulsation involves heating the palpebral surfaces of the upper and lower lids while simultaneously applying graduated pulsatile pressure to the outer eyelid surface. It is designed to milk the secretions from the base of the meibomian gland to the gland orifices. The single eyelid thermal pulsation system being marketed (e.g. LipiFlow®System) was classified by the FDA in 2011 as a class II device for use in adults with chronic cystic conditions of the eyelids, including MGD.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

The data is insufficient to determine the effects of thermal pulsation on long term health outcomes, because nearly all evidence is derived from industry-funded studies. Independent trials with long term follow-up are needed to assess durability of effect.

SOURCES 

American Academy of Ophthalmology Cornea/External Disease PPP Panel. (2013). Dry eye syndrome PPP - 2013. Retrieved November 14, 2013 from http://www.aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp--2013.

Baumann, A., & Cochener, B. (2014). Meibomian gland dysfunction: a comparative study of modern treatments. Journal Français d'Ophtalmologie, 37 (4), 303-312. Abstract retrieved November 14, 2016 from PubMed database.

Blackie, C. A., Coleman, C. A., & Holland, E. J. (2016). The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye. Clinical Ophthalmology, 10, 1385-1396. (Level 5 evidence – Industry sponsored)

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2017). Eyelid thermal pulsation for the treatment of dry eye syndrome. (9.03.29). Retrieved October 23, 2017 from BlueWeb. (16 articles and/or guidelines reviewed)

National Institute for Health and Care Excellence (2015, April) Medtech: LipiFlow thermal pulsation treatment for dry eyes caused by blocked meibomian glands. Retrieved October 23, 2017 from www.nice.org.

Nichols, K., Foulks, G., Bron, A., Glasgow, B., Dogru, M., Tsubota, K., et al. (2011). The international workshop on meibomian gland dysfunction: Executive summary. Investigative Ophthalmology and Visual Science, 52 (4), 1922-1929. (Level 5 evidence - Industry sponsored)

Satjawatcharaphong, P., Ge, S., & Lin, M. C. (2015). Clinical outcomes associated with thermal pulsation system treatment. Optometry and Vision Science, 92 (9), e334-e341. Abstract retrieved November 14, 2016 from PubMed database.

Schallhorn, C., Schallhorn, J., Hannan, S., and Schallhorn, S. (2017, January) Effectiveness of an Eyelid Thermal Pulsation Procedure to Treat Recalcitrant Dry Eye Symptoms After Laser Vision Correction. Journal of Refractory Surgery, 33 (1), 30-36. Abstract retrieved October 23, 2017 from PubMed database.

U. S. Food and Drug Administration. (2011, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K112704 (LipiFlow® Thermal Pulsation System). Retrieved October 23, 2017 from http://www.accessdata.fda.gov .

Zhao, Y., Veerappan, A., Yeo, S., Rooney, D., Acharya, R., Tan, J., et al. (2016, November) Clinical trial of thermal pulsation (LipiFlow) in meibomian gland dysfunction with pre-treatment meibography. Eye & Contact Lens, 42 (6), 339-346. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  7/13/2013

MOST RECENT REVIEW DATE:  12/14/2017

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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Keywords: Pulsed Light Therapy