DESCRIPTION
Both hemangiomas and port wine stains are vascular disorders. Hemangiomas refer to various different types of lesions including 'strawberry nevus hemangioma', 'cavernous hemangioma' and 'capillary-cavernous hemangioma'. The lesion color will depend on its location beneath the epidermis and the presence of oxygen saturated blood in its vessels. Hemangiomas usually develop at the age of 2 months, but occasionally appear at birth. They usually disappear (in 90-95% of individuals) by age 9. Girls are more commonly affected by hemangiomas.
Port-wine stains (PWS) are a vascular birthmark, and most often appear on the face and neck. They occur in equal rates in males and females. Color varies from a pale pink to deep red during infancy to a red or purple during middle age, but all have a flat and sharply demarcated surface. PWS do not disappear with age, and are often associated with complications. Dye laser therapy is the treatment of choice for PWS, and is effective for children and infants because it is not associated with postoperative scarring.
A laser is a highly focused beam of light that is converted to heat when absorbed by pigmented skin lesions. The resulting damage causes gradual destruction of hemangiomas or port wine stains. Carbon dioxide and argon lasers have an increased incidence of significant scarring in children, whereas tunable dye lasers result in less scarring.
The intense pulsed light source (IPLS; e.g., PhotoDerm VL®) emits high-energy flashlamp non-coherent light. The IPLS functions are based on the principle of selective photothermolysis, making it possible to damage selected targets within the tissue. Evidence supports the use of the IPLS for treatment of port wine stains when there is treatment failure with dye laser therapy.
POLICY
Laser therapy for the treatment of congenital port wine stains and hemangiomas is considered medically necessary.
The intense pulsed light sources for the treatment of congenital port wine stains, when there is documented evidence of treatment failure with laser, is considered medically necessary.
The intense pulsed light source for the treatment of hemangiomas is considered investigational.
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
The lack of randomized controlled trials and published studies provide little evidence of the safety and efficacy to support the use of intense pulsed light source for the treatment of hemangiomas.
SOURCES
Asahina, A., Watanabe, T., Kishi, A., Hattori, N., Shirai, A., Kagami, S, et al. (2006). Evaluation of the treatment of port-wine stains with the 595-nm long pulsed dye laser: A large prospective study in adult Japanese patients. Journal of the American Academy of Dermatology, 54 (3), 487-493. (Level 2 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (2003, February). Laser treatment of congenital port wine stain hemangiomas (7.01.40). Retrieved July 26, 2009 from BlueWeb. (0 articles and/or guidelines reviewed)
Christison-Lagay, E. R., & Fishman, S. J. (2006). Vascular anomalies. Surgical Clinics of North America, 86 (2), 393-425.
Garzon, M., Huang, J. T., Enjolras, O., & Frieden, I. J. (2007). Vascular malformations. Part 1. Journal of the American Academy of Dermatology, 56 (3), 353-370.
Hayes. Medical Technology Directory. (2006, January). Pulsed dye laser therapy for cutaneous vascular lesions. Retrieved May 22, 2007 from www.Hayesinc.com/subscribers. (54 articles and/or guidelines reviewed)
Legiehn, G. M., & Heran, M. K. S. (2006). Classification, diagnosis, and interventional radiologic management of vascular malformations. Orthopedic Clinics of North America, 37 (3), 435-474.
Legiehn, G. M., & Heran, M. K. S. (2008). Venous Malformations: Classification, development, diagnosis, and interventional radiologic management. Radiologic Clinics of North America, 46 (3), 545-597.
McLaughlin, M. R., O’Connor, N. R., & Ham, P. (2008). Newborn skin: Part II. Birthmarks. American Family Physician, 77 (1), 56-60.
National Institute for Health and Clinical Excellence (NICE). (2004, September). Intralesional photocoagulation of subcutaneous congenital vascular disorders. Retrieved June 26, 2009 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG090guidance.pdf.
Peralejo, B., Beltrani, V., & Bielory, L. (2008). Dermatologic and allergic conditions of the eyelid. Immunology and Allergy Clinics of North America, 28 (1), 137-168.
Schmults, C. D. (2005, October). Current therapy: Laser treatment of vascular lesions. Dermatologic Clinics, 23 (4), 745-755.
Stier, M. F., Glick, S. A., & Hirsch, R. J. (2008). Laser treatment of pediatric vascular lesions: Port wine stains and hemangiomas. Journal of the American Academy of Dermatology, 58 (2), 261-285.
U. S. Food and Drug Administration. (1996, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K960772. Retrieved June 26, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K960772.pdf.
U. S. Food and Drug Administration. (2002, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K020839. Retrieved June 26, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/K020839.pdf.
U. S. Food and Drug Administration. (2002, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K022266. Retrieved June 26, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022266.pdf.
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 7/9/2009
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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