Archived Policies - Surgery
Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and Other External Vascular Malformations
Laser treatment of port wine stain, hemangiomas, and other external vascular malformations that are present from birth and have medical record documentation of progressive functional impairment may be considered medically necessary.
Laser treatment of acquired hemangiomas and other external vascular malformations that is performed primarily to alter or enhance appearance is considered cosmetic.
NOTE: Special Comment regarding Cosmetic Service—Determination of benefit coverage for procedures considered to be cosmetic is based on how a member's benefit contract defines cosmetic services and their eligibility for benefit coverage. Coverage of laser treatment of port wine stains, hemangiomas, and other external vascular malformations will depend on benefit language related to definitions of medically necessary, reconstructive, and cosmetic services. Procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma and treatment of a disease or congenital defect.
Treatment of port wine stain, hemangiomas, and other external vascular malformations with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered experimental, investigational and unproven.
SPECIAL DOCUMENTATION REQUIREMENT NOTE: The plan may request medical records for determination of medical necessity. When medical records are requested, a letter of support and/or explanation is helpful, but alone will not be considered sufficient documentation to make a medical necessity determination.
A laser is a highly focused beam of light that is converted to heat when absorbed by pigmented skin lesions. The laser selects the reddened areas and shrinks the vessels, resulting in gradual destruction of the malformation. The result is a less noticeable lesion. Repeated treatments can sometimes almost completely remove superficial components. Currently, the most common in clinical practice is the pulsed dye laser (PDL). Performance of a prior spot test is necessary to determine if laser treatment would be suitable for the patient and approximate what the degree of scarring may be. The size of the lesion may require more than one treatment. Treatment of an extensive area and/or the age of the patient may require intravenous anesthesia.
Port Wine Stains (PWS)
Port wine stains, also known as nevus flammeus or capillary malformations, are present at birth and begin as pale pink flat areas in childhood that consist of malformed, dilated blood vessels on the skin and occur in approximately 0.3-0.5% of individuals in the United States. These lesions occur equally in both sexes. Lesions tend to grow commensurately with the patient, without a tendency towards regression. Lesions are usually located on the face and the abnormal blood vessels within the PWS become progressively more dilated in size which results in the lesion becoming dark purple and elevated in some instances. Nodules and hypertrophy may develop in the soft tissue underlying the PWS. Nodules may continue to grow and begin to bleed easily if traumatized. Most PWS are superficial, particularly in the forehead and cheeks regions, and may be associated with other medical problems such as glaucoma. Use of the PDL is the preferred treatment because of its superior efficacy and low prevalence of adverse effects.
Hemangiomas are abnormally dense collections of benign, dilated, small blood vessels occurring in 10-12% of all children by one year of age, may occur in the skin or internal organs, and may be present anywhere on the body. However, they have the most psycho-social impact when they appear on the face or head. The classically recognized hemangioma is a visible red skin lesion that may be superficial, called a capillary hemangioma, a skin lesion that goes deeper than a superficial lesion (cavernous hemangioma), or a mixture of both. These lesions are usually present at birth, although they may appear within a few months after birth, often beginning at a site that has appeared slightly dusky or colored differently than the surrounding tissue. Hemangiomas of the eyelid may interfere with the development of normal vision and must be treated in the first few months of life. On rare occasions, the size and location of hemangiomas may interfere with breathing, feeding, or other vital functions. Superficial hemangiomas may disappear completely over time without treatment.
Other Vascular Malformations
Stork bite is a common type of birthmark seen in newborns that is due to a dilation of blood vessels, and usually disappears by about 18 months, although stork bite on the back of the neck may not disappear. Angel's kisses are usually seen on the forehead, eyelids, tip of nose, or upper lip, and usually disappear by two years of age. Stork bites and angel’s kisses are harmless and require no treatment. However, these may be removed with a laser to improve the patient’s appearance.
Telangiectasis is small, dilated, superficial blood vessels near the surface of the skin. These can be treated with laser or sclerotherapy; treatment is usually cosmetic.
Cherry angiomas are benign skin growths of unknown cause that vary in size, usually develop on the trunk, and are more common after age 30. They are also called senile angioma. Cherry angiomas generally do not need to be treated, but they may be removed by cautery, cryotherapy, laser, or surgery.
Laser treatment is a well-established method of reducing port-wine stain, hemangiomas and other external vascular malformations. Lasers treat the dilated vessels of the malformation and do not injure the surrounding epidermis, dermis, and other soft tissue structures. The safety and effectiveness have been proven by clinical experience worldwide.
It is of significant advantage to treat these lesions early on, as the lesions are not hypertrophied, as well-matured or as prominent. Treatment at an early age is met with significant early resolution and requires fewer treatments.
The following is a summary of the key literature to date on the safety and effectiveness of laser treatment for port wine stains. There is no new literature available on the safety and effectiveness of laser treatment for hemangiomas, and other external vascular malformations other than that included in the studies of port wine stains.
A systematic review published in 2005 identified 71 articles on pulsed dye laser treatment for port-wine stains. Thirty-eight of the 71 articles (54%) were prospective, 24 (34%) were based on objective measurement of outcomes and 17 (24%) included control groups. One objective measurement is change in the color of the port wine stain after treatment as assessed by a colorimeter. Studies have found that laser treatment results in approximately a 12% lightening of the lesion per treatment. Lesions on the forehead, lateral face, neck and trunk tended to respond more favorably than lesions on the central face, lip, chin and extremities. The studies reviewed did not find that lengthening the pulse duration or increasing the wavelength of the laser led to improvements.
Several review articles affirm that the pulsed dye laser is currently the standard treatment for port wine stains. Stier and colleagues note that the single parameter setting for pulsed dye lasers is unclear. However, in general the parameters used are 585 to 600 nm wavelengths, 4 to 12 j/cm2 fluence, 1.5 to 10 ms pulse duration and a minimum 7 mm spot size. Their review of the literature found that the marginal treatment effect decreases as the number of treatments increases, but that there tends to be a slow improvement over time with prolonged treatment.
Cordisco and colleagues discuss options for patients who do not respond to treatment with pulsed dye lasers. The authors comment that it is not currently clinically possible to define criteria that will predict who will respond to pulsed dye laser treatment. Other interventions are proposed for patients with treatment-resistant port wine stains. This includes a combined pulsed dye and Nd: YAG laser (Cynergy Multiplex, Cynosure Inc.). Several unpublished studies were cited in support of this combined device. Another option, specifically for treatment-resistant patients whose port wine stains have a purple or blue tinge, is use of a more deeply penetrating laser such as the 1064 Nd: YAG. Other treatments under investigation are photodynamic therapy and pulsed dye laser treatment combined with a topical agent such as angiogenesis inhibitors. The authors point out that the effects of topical angiogenesis inhibitors need to be studied in prospective controlled studies.
No prospective controlled studies evaluating photodynamic therapy or topical angiogenesis inhibitors were identified. A search of the National Clinical Trials Database identified one study underway that is evaluating combined pulsed dye laser and photodynamic therapy. There are also several ongoing studies examining the effectiveness of pulsed dye lasers combined with a topical agent; there is one trial each on topical ranibizumab, imiquimod and tacrolimus/pimecrolimus. As of May 2010, all of the studies identified in the National Clinical Trials Database are in the patient recruitment phase.
Studies have generally found that laser treatment can be effective at lightening port wine stains.
There is insufficient evidence that the combination of laser treatment and photodynamic therapy or topical agents is superior to laser treatment alone for improving the appearance of port wine stains or reducing complications. In addition, although hemangiomas have been successfully treated with lasers (i.e., PDL), hemangiomas and other external vascular malformations have only been studied in clinical trials using lasers in combination with photodynamic therapy when combined with PWS; there are no specific studies available that addressed treatment of hemangiomas and other vascular malformations with laser in combination with photodynamic therapy.
Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
Rothfeisch, J. E. Laser Treatment of congenital and acquired vascular lesions. A review. Dermatologic Clinics. (2002 January) 20(1):1-18.
Loo, W.J., and S.W. Lanigan. Recent ain laser therapy for the treatment of cutaneous vascular disorders. Lasers in Medical Science. (2002) 17(1):9-12.
Lorenz, S., Scherer, K., et al. Variable pulse frequency-doubled Nd: YAG laser versus flashlamp-pumped pulsed dye laser in the treatment of port wine stains. Acta Dermato Venereologica. (2003):210-3.
Hamilton, M.M. Laser treatment of pigmented and vascular lesions in the office. Facial Plastic Surgery (2004 February) 20(1):63-9.
Smite, J.M., Badland, C.G., et al. Pulsed dye laser treatment, a review of indications and outcome based on published trials. British Journal of Plastic Surgery (2005) 58(7):981-7.
Bernstein, S.F. High-energy 595 pulsed dye laser improves refractory port-wine stains. Dermatologic Surgery (2006 January) 32(1):26-33.
Woo, S.H., Ahn, H.H., et al. Treatment of vascular skin lesions with the variable-pulse 595 nm pulsed dye laser. Dermatologic Surgery (2006 January) 32(1):41-8.
Kono, T., Groff, W.F., et al. Evaluation of fluence and pulse-dye laser in the treatment of port-wine stains. Journal of Dermatology (2006 July) 33(7):473-6.
Lee, B.B., Laredo, J., et al. Terminology and classification of congenital vascular malformations. Phlebology (2007) 22(6):249-52.
Kantor, J. and D. Zieve. Telangiectasia. MedLine Plus. U.S. National Library of Medicine (2008, October 3) Available at <www.nlm.nih.gov/medlineplus> (accessed on 2009, April 15).
Berman, K. and D. Zieve. Cherry Angioma. MedLine Plus. U.S. National Library of Medicine (2008, October 3) Available at <www.nlm.nih.gov/medlineplus> (accessed on 2010, November 3).
Stier, M.F., Glick, S.A., et al. Laser treatment of pediatric vascular lesions: Port wine stains and hemangiomas. Journal of the American Academy of Dermatology (2008) 58(2):261-85.
Cordisco, M.R. An update on lasers in children. Current Opinions in Pediatrics (2009) 21(4):499-504.
Faurschou, A., Togsveri-Bo, K., et al. Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by-side intense pulsed light for port-wine stains: a randomized side-by-side trial with blinded response evaluation. British Journal of Dermatology (2009 February) 160(2):359-64.
Sidoroff, A. Epidemiologie of cutaneous vascular neoplasms and malformation in childhood. Handchirurgie, Mikrochirurgie, Plastische Chirurgie (2009 April) 41(2):65-9.
Kaneshiro, N.K., and D. Zieve. Stork Bite. MedLine Plus. U.S. National Library of Medicine (2009, June 2) Available at <www.nlm.nih.gov/medlineplus> (accessed on 2010, November 3).
Minkis, K., Geronemue, R.G., et al. Port wine stain progression of delayed and inadequate treatment? Lasers Surg Med (2009 August) 41 (6):423-6.
National Institutes of Health - Clinicaltrials. Port Wine Stains Treatment Matrix RF Study. Evaluation of Fractional Radiofrequency (Matrix RF) Stand Alone and Combined with PDL Treatment on Port Wine Stains. NCT01101360 (2010 July). Available at <clinicaltrials.gov>. (accessed – 2010 May).
Telangiectasia. International Scleroderma Network. (2010). Available at <www.sclero.org> (accessed 2010, November 3).
Vascular Birthmarks. American Academy of Dermatology. 2010. Available at <www.aad.org> (accessed 2010, November 3).
Birthmarks.com. Vascular abnomalies. Arkansas Children’s Hospital: Little Rock, Arkansas. Available at <www.birthmarks.org>. (accessed – 2010 August 2).
eMedicine - Laser treatment of acquired and congenital vascular lesions. (2010 June). Available at <emedicine.medscape.com> (accessed – 08/02/2010).
Laser Treatment of Port Wine Stains. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 June) Surgery 7.01.40.
4/1/2011 Document updated with literature review. The following was added: reatment of port wine stain, hemangiomas, and other external vascular malformations with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered experimental, investigational and unproven. The title changed from Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and External Vascular Malformations.
6/15/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
5/15/2007 Revised/updated entire document
1/1/2005 Revised/updated entire document
11/2000 Revised/updated entire document
9/1999 Revised/updated entire document
5/1996 Revised/updated entire document
7/1994 Revised/updated entire document
7/1993 Revised/updated entire document
5/1990 New medical document
|Title:||Effective Date:||End Date:|
|Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and Other External Vascular Malformations||04-15-2018||03-31-2020|
|Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and Other External Vascular Malformations||03-15-2016||04-14-2018|
|Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and External Vascular Malformations||06-15-2008||03-31-2011|
|Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and External Vascular Malformations||05-15-2007||06-14-2008|
|Laser Treatment of Congenital Port Wine Stain (PWS), Hemangiomas, and External Vascular Malformations||01-01-2005||05-14-2007|
|Laser Treatment of Congenital Port Wine Stain (PWS) Hemangioma||11-01-2000||12-31-2004|