DESCRIPTION
Blue light (i.e., ClearLight™) is a high intensity lamp intended for the treatment of acne vulgaris. It emits ultraviolet free visible light in the violet-blue spectrum. The wavelengths range from 415 to 660 nanometers (nm). It is thought that the violet-blue spectrum of high-intensity light triggers the proliferation of endogenic porphyrins, which attack and destroy the acne bacteria within the skin.
POLICY
Blue light for the treatment of acne vulgaris is considered investigational.
See also: Photodynamic Therapy (PDT) for Dermatologic Conditions
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of long term follow-up data from well-designed large randomized controlled studies. Published literature does not validate the safety and efficacy of using Blue light for acne vulgaris and studies do not indicate improved health outcomes with Blue light compared to the results of using conventional therapies.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2011). Dermatologic applications of photodynamic therapy. (2.01.44). Retrieved June 13, 2011 from BlueWeb. (33 articles and/ or guidelines reviewed)
Hamilton, F. L., Car, J., Lyons, C., Car, M., Layton, A., & Majeed, A. (2009). Laser and other light therapies for the treatment of acne vulgaris: Systematic review. British Journal of Dermatology, 160 (6), 1273-1285.
Kim, R. H., & Armstrong, A. W. (2011). Current state of acne treatment: Highlighting lasers, photodynamic therapy, and peels. Dermatology Online Journal, 17 (3), 2.
Lolis, M. S., Bowe, W., & Shalita, A. R. (2009). Acne and systemic disease. Medical Clinics of North America, 93 (6), 1161-1181.
Nestor, M. (2007). The use of photodynamic therapy for treatment of acne vulgaris. Dermatologic Clinics, 25 (1), 47-57.
Thiboutot, D., Gollnick, H., Bettoli, V., Dreno, B., Kang, S., Leyden, J., et al. (2009). New insights into the management of acne: An update from the Global Alliance to Improve Outcomes in Acne Group. Journal of American Academy of Dermatology, 60 (5 Suppl.), S1-S50.
U. S. Food and Drug Administration. (2010, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K100378. Retrieved June 13, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100378.pdf.
U. S. Food and Drug Administration. (2008. November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080591. Retrieved June 13, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080591.pdf.
U. S. Food and Drug Administration. (2005, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K051259. Retrieved June 13, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051259.pdf.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K013623. Retrieved June 13, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf/k013623.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, February). Phototherapy for acne vulgaris. Retrieved June 13, 2011 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines reviewed)
Yan, A. (2006). Current concepts in acne management. Adolescent Medical Clinics, 17 (3), 613-637.
ORIGINAL EFFECTIVE DATE: 3/1/2004
MOST RECENT REVIEW DATE: 7/14/2011
ID_BT
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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