Laser Treatment of Congenital Port Wine Stain Hemangiomas
DESCRIPTIONPort wine stains are the most common of the vascular malformations, affecting approximately 3 in 1000 children. They are composed of networks of ectactic vessels and primarily involve the papillary dermis. Unlike many other birthmarks, port wine stains do not resolve spontaneously. In contrast, they typically begin as pink macules and become redder and thicker over time due to decreased sympathetic innervation. The depth of the skin lesions ranges from about 1 to 5 mm. Port wine stains are generally located on the face and neck, but can occur in other locations such as the trunk or limbs.
Hemangioma is defined as a benign tumor of dilated blood vessels. It is confusing to attempt to classify hemangiomas on the basis of their histology. For example, the histologic term capillary hemangioma is used for both the common involuting hemangioma of childhood that disappears by age 7 and the port wine stain that persists into adulthood. The term cavernous is used to designate several types of hemangiomas that behave quite differently. Some hemangiomas are true neoplasms arising from endothelial cells and other vascular elements (such as involuting hemangiomas of childhood, endotheliomas, and pericytomas). Others are not true neoplasms but rather malformations of normal vascular structures (e.g., port wine stains, cavernous hemangiomas, and arteriovenous fistulas).
Prior to the availability of laser treatment in the 1980s, there were no effective therapies for port wine stains. A laser is a highly focused beam of light that is converted to heat when absorbed by pigmented skin lesions. Several types of lasers have been used to treat port wine stains. Currently, the most common in clinical practice is the pulsed dye laser (PDL) which uses yellow light wavelengths (585-600nm) that selectively target both oxyhemoglobin and deoxyhemoglobin. Pulsed dye lasers penetrate up to 2 mm in the skin. Newborns and young children, who have thinner skin, tend to respond well to this type of laser the response in thicker and darker lesions may be lower. Other types of lasers with greater tissue penetration and weaker hemoglobin absorption are used for hypertrophic and resistant port-wine stains. In particular, alternatives to the pulsed-dye laser are the long-pulsed 1064 nm Nd: YAG and 755 nm pulsed Alexandrite lasers. The 1064 nm Nd:YAG laser requires a substantial amount of skill to use to avoid scarring. Carbon dioxide and argon lasers are relatively non-selective; they were some of the first lasers used to treat port wine stains, but were associated with an increased incidence of scarring and are not currently used frequently in clinical practice to treat port wine stains.
The Tuneable Dye Argon Laser has FDA approval. The machine's primary use is the treatment of port wine stain hemangiomas but it can also be used to treat other blood vessels abnormalities, e.g., capillary or cavernous hemangiomas or significant telangiectasia. Treatment with a tuneable dye argon laser has virtually eliminated the risk of scarring (less than 1%) and is now considered the treatment of choice. Four to six treatments are usually required. Occasionally, a patient can get by with three and may need up to eight treatments, but generally never more than eight.
Several other laser systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for a variety of dermatologic indications, including treatment of port wine stains. Approved lasers for this indication include the Candela pulsed-dye laser system (Candela Corp.; Wayland, MA), the Cynosure Photogenica pulsed-dye laser (Cynosure Inc; Westford, MA) and the Cynosure Nd:YAG laser system.
POLICYTreatment of congenital hemangiomas may depend on contract language pertaining to cosmetic versus reconstructive surgery and congenital versus functional impairment definitions.
The use of a laser is an effective treatment of congenital hemangiomas (port wine stains). Since these vascular malformations are present at birth, and are permanent and disfiguring when located on the face. Coverage decisions should be based on the size and location of the lesions.
Laser treatment of port wine stains in the presence of functional impairment may be considered medically necessary.
It is considered medically necessary to remove nodular hemangiomas developing in a previously flat port wine stain in children and adults. When nodules are present on the mouth, lips or gums, the lesions can effect speech. Nodularity in close proximity to the eye can effect vision.
Performance of a prior test spot is necessary to select suitable candidates for treatment and to determine the degree of scarring which may occur.
More than one treatment may be required.
Local anesthesia is routinely used; however, dependent on the age of the patient and the extent of the treatment area, conscious sedation or general anesthesia may be necessary.
Use of a laser to remove decorative tattoos is considered cosmetic and is not medically necessary.
Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY10/1993: Approved by Medical Policy Advisory Committee (MPAC)
4/5/2001: Policy reviewed; Managed Care Requirements deleted
11/14/2001: Sources updated
3/6/2002: Individual consideration requirement deleted
5/1/2002: Type of Service and Place of Service deleted
8/19/2003: ICD-9 diagnosis code range 228.01-228.09 listed separately
2/13/2004: Code Reference section updated, ICD-9 diagnosis code 228.02, 228.03, 228.04, 228.09 deleted
10/23/2006: Policy reviewed, no changes
6/6/2008: Removed "Up to six (6) local treatments of port wine stain hemangiomas by the Tuneable Dye Argon Laser are considered medically necessary", from policy statement.
07/15/2010: Policy description updated to provide additional information about port wine stains, treatment approaches, and devices. Added the following to the policy statement: (1) Laser treatment of port wine stains in the presence of functional impairment may be considered medically necessary. (2) Treatment with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered investigational. FEP verbiage added to the Policy Exceptions section.
08/02/2011: Added "port wine stains" to the last policy statement for clarity purposes.
07/17/2012: Policy reviewed; no changes.
10/23/2013: Policy reviewed. Policy statement updated to change "intravenous anesthesia" to “conscious sedation or general anesthesia" for clarity purposes.
07/15/2014: Policy reviewed; no changes.
07/10/2015: Policy reviewed; no changes.
08/31/2015: Code Reference section updated for ICD-10.
06/01/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
SOURCE(S)Hayes Medical Technology Directory
Blue Cross Blue Shield Association policy #7.01.40
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.