Port-wine stains (PWS) are congenital vascular malformations of the skin that affect approximately 0.3% to 0.5% of newborns; the exact cause is unknown. PWS are chronic lesions characterized by enlarged and dilated venules and capillaries in the superficial dermis; the lesions can extend into deeper vessels of the dermis and subcutaneous tissues. At birth, the lesions typically appear as flat, faint, pink macules. With increasing age, they darken and become raised, red-to-purple nodules and papules in adults. Found most often on the face, neck, arms, or legs; PWS can arise anywhere on the body and vary in size. Due to their potential for disfigurement, PWS can cause negative emotional and social consequences; thus, early treatment is usually recommended to prevent enlargement, to improve the patient’s appearance, and to reduce the likelihood of medical 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.
Congenital hemangiomas are benign tumors of the vascular endothelium that appear at or shortly after birth, usually within 4 to 6 weeks. They occur in 1% to 3% of newborns and in 10% to 20% of children by 1 year of age; 15% to 30% of infants with lesions have multiple lesions. Hemangiomas are characterized by a 6- to 12-month period of proliferation during which they grow to a size of 2 to 20 centimeters (cm).
Lasers are used to treat both PWS and hemangiomas. The flashlamp-pumped pulsed dye laser (PDL), introduced in 1985 (e.g. Candela® PDL system, Cynosure Photogenica® PDL) was developed specifically for the treatment of cutaneous vascular lesions. PDL emits one specific color (yellow), or wavelength, of light that can be varied in its intensity and pulse duration. PDL therapy is administered in multiple sessions in an outpatient setting, with or without topical, local, or general anesthesia. Other types of lasers such as the intense pulsed light source (IPLS; e.g., PhotoDerm VL®) with greater tissue penetration are also used for resistant port wine stains.There are also a number of other therapies under investigation for the treatment of PWS and hemangiomas such as photodynamic therapy (PDT) and angiogenesis inhibitors. PDT is a treatment that uses a drug, called a photosensitizer or photosensitizing agent, and a specific wavelength of light. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills nearby cells. Topical angiogenesis inhibitors block vascular tissue growth.
Laser therapy (e.g., pulse dye laser, intense pulse light source), for the treatment of congenital port wine stains and hemangiomas is considered medically necessary.
Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
There is insufficient evidence that lasers combined with another treatment, e.g. photodynamic therapy or topical angiogenesis inhibitors, is superior to laser treatment alone.
Agency for Healthcare Research and Quality (2016, January) Comparative effectiveness review no. 168, diagnosis and management of infantile hemangioma. Retrieved August 1, 2016 from: http://www.ahrq.gov.
Brightman, L. A., Geronemus, R. G., & Reddy, K. K. (2015). Laser treatment of port-wine stains. Clinical, Cosmetic and Investigational Dermatology, 2015 (8), 27-33. Retrieved September 9, 2015 from PubMed database. (Level 5 evidence)
Cerrati, E. W., O, T. M., Binetter, D., Chung, H., & Waner, M. (2014). Surgical treatment of head and neck port-wine stains by means of a staged zonal approach. Plastic Reconstruction Surgery, 134 (5), 1003-1012. Abstract retrieved August 1, 2016 from PubMed database. (Level 4 evidence)
National Government Services, Inc. (2015, October) Local coverage article: Removal of benign skin lesions (A54602). Retrieved May 18, 2017 from https://www.cms.gov.
Shi, W., Wang, J., Lin, Y., Geng, J., Wang, H., Gong, Y., et al. (2014). Treatment of port wine stains with pulsed dye laser: a retrospective study of 848 cases in Shandong Province, People’s Republic of China. Journal of Drug Design, Development and Therapy, 2014; 8, 2531-2538. (Level 4 evidence)
U. S. Food and Drug Administration. (2007, July). Center for Devices and Radiological Health.510(k) Premarket Notification Database. K063427.(LUMINA Intense Pulse Light System) Retrieved May 4, 2012 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2011, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K110304 (Apex Er:YAG/IPL System). Retrieved May 4, 2012 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search December 2016). Pulsed dye laser therapy for cutaneous vascular lesions. Retrieved May 18, 2017 from www.Hayesinc.com (114 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 7/13/2017
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