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Medical Policy

Policy Num:      07.001.081
Policy Name:    Laser Treatment of Port Wine Stains and other Vascular Lesions of the Skin
Policy ID        [07.001.081][Ar L M+ P+][7.01.40]

Last Review:    March 25. 2026
Next Review:    Archived
 

Related Policies:

02.001.010 Nonpharmacologic Treatment of Rosacea

08.001.031 Chemical peels

02.001.069 Dermatologic Application of Photodynamic Therapy

07.001.013 Treatment if Varicose Veins/Venous insufficiency

02.001.017 Laser Treatment of Active Acne

02.001.070 Laser Treatment of Onychomycosis

Laser Treatment of Port Wine Stains and other Vascular Lesions of the Skin
 

Summary

Description

Destruction of cutaneous vascular proliferative lesions (CVPLs) involves the use of laser or other light-based technologies to ablate superficial vascular growths, such as hemangiomas, port-wine stains, and other vascular malformations. These lesions may be congenital or acquired and can cause a range of complications depending on size, location, and progression.

Summary of Evidence

Objective

The objective of this review is to evaluate the use of laser therapy for patients with cutaneous vascular proliferative lesions, including port-wine stains and hemangiomas.

Policy Statement

Laser therapy for port wine stains and other vascular lesions of the skin may be considered medically necessary when ALL of the following criteria are met:

1. Diagnosis of a clinically significant vascular lesion, including but not limited to:

• Capillary hemangioma (e.g., infantile hemangioma)
• Congenital vascular malformation (e.g., port-wine stain)
• Arteriovenous malformation or other cutaneous vascular anomaly
• Syndromic vascular lesions (e.g., Sturge-Weber, PHACES, HHT)

2. Lesion causes or is associated with at least one of the following:

• Bleeding or ulceration
• Recurrent trauma or irritation (e.g., over joints or scalp)
• Pain or tenderness interfering with daily activities
• Functional impairment (e.g., vision obstruction, airway compromise, feeding/speech interference)
• Progressive growth or documented change in lesion

Laser therapy is considered cosmetic and/or investigational as a treatment of port wine stains and other vascular lesions of the skin when the above criteria are not met.

Policy Guidelines

The size of the lesion may require more than 1 treatment.

Supporting documentation must include:

• Description and location of lesion
• Size in cm²
• Duration and progression of symptoms
• Prior treatment attempts (if any)
• Photographs
• Impact on function or quality of life

Triple S will considers the following dermatologic conditions investigational and/or cosmetic for Laser treatment (list is not all inclusive).

Rosacea (Please refer to Triple-S medical policy 02.001.010)

Telangiectasia / spider veins (Please refer to Triple-S medical policy 07.001.013)

Nevus NOS

Tattoo removal

Rhinophyma

Seberheic Keratosis

Actinic/Solar Keratosis (Please refer to Triple-S medical policy 02.001.069)

Chemical Peels AK / Acne (Please refer to Triple-S medical policy 08.001.031)

Sun damage

Melasma

Benefit Application

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Cutaneous vascular proliferative lesions encompass a spectrum of congenital and acquired vascular abnormalities of the skin, including port-wine stains (capillary malformations), infantile hemangiomas, and other vascular malformations. These lesions may present at birth or manifest early in life, with clinical significance determined by lesion size, anatomical location, and potential for associated complications.

Port-wine stains are characterized by persistent reddish to purple discolorations, commonly involving the face and neck. Left untreated, these lesions may darken, thicken, and lead to functional impairment or psychosocial morbidity. Infantile hemangiomas are benign vascular tumors marked by an initial proliferative phase followed by involution; however, certain hemangiomas may ulcerate, bleed, or interfere with essential functions such as vision, feeding, or respiration.

Laser therapy, particularly pulsed dye laser (PDL), is considered the standard treatment for many cutaneous vascular lesions. Other laser modalities, including Nd:YAG, Alexandrite, and intense pulsed light (IPL), may be employed based on lesion characteristics and patient factors. Treatment typically requires multiple sessions over time, with clinical outcomes influenced by lesion type, size, and response to therapy.

Regulatory Status

Various laser systems have received clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) premarket notification process for the treatment of benign cutaneous vascular lesions. Notable examples include:

• The Vbeam® Pulsed Dye Laser System (Syneron Candela), cleared for treatment of port-wine stains, hemangiomas, telangiectasias, and rosacea.

• The Excel V™ Laser (Cutera), cleared for a broad range of vascular and pigmented lesions.

• The GentleYAG® Laser (Candela), cleared for treatment of leg veins and other vascular indications.

These devices are classified as Class II medical devices and are regulated based on substantial equivalence to predicate devices rather than through rigorous clinical trial data submission. FDA clearance denotes that these devices meet safety standards and intended use criteria; however, it does not constitute an endorsement of medical necessity or guaranteed coverage.

Rationale

This evidence review was created in October 2006 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through March 10, 2025.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Clinical Context and Therapy Purpose

The purpose of  laser therapy in vascular proliferative lesions is to provide a treatment option for individuals with clinically significant vascular anomalies—such as infantile hemangiomas, port-wine stains, and syndromic vascular lesions—that are associated with bleeding, ulceration, functional impairment, or other medically relevant complications. The goal is to prevent or reduce morbidity associated with lesion growth, location, or chronic symptoms.

The question addressed in this evidence review is: Does the use of laser therapy improve the net health outcome in individuals with medically significant vascular lesions of the skin?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with clinically significant vascular lesions of the skin.

Interventions

Frequency and duration of laser and light therapy sessions vary, from once to twice per month, for several months. Because light-based techniques do not cure rosacea, periodic treatments may be necessary to maintain symptom relief.

Comparators

The comparators of interest are pharmacologic therapies, which include oral and topical antibiotics, isotretinoin, β-blockers, alpha₂-adrenergic agonists (e.g., oxymetazoline, clonidine), and anti-inflammatories. The selection of a pharmacological agent is dependent on the clinical features present for an individual patient (e.g., redness, edema, papules and pustules).

Outcomes

The general outcome of interest is symptom reduction, which may include a change in redness of skin color or change in erythema score or telangiectasia score. Other outcomes of interest include a reduction in pain, subject satisfaction, and improvement in the quality of life.

Outcome measures can be assessed on treatment completion. Because laser and light therapy are not curative, outcomes can be measured months after treatment to assess symptom recurrence.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse effects, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Consistent with a 'best available evidence approach,' within each category of study design, studies with larger sample sizes and longer durations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Systematic Reviews

Population Reference No. 1 Policy Statement

For individuals with suspected glaucoma with clinically significant vascular lesion. Intervention of interest is Laser therapy compared with standard of care. Relevant outcomes are symptoms, functional outcomes, quality of life and treatment-related morbidity. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Suplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

None

References

1. Faurschou A, Olesen AB, Leonardi-Bee J, et al. Lasers or light sources for treating port-wine stains. Cochrane Database Syst Rev. 2011(11):CD00715

2. PMID 22071834 2. Faurschou A, Togsverd-Bo K, Zachariae C, et al. Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by-side trial with blinded response evaluation. Br J Dermatol. Feb 2009;160(2):359-364. PMID 19120324

3. Babilas P, Schreml S, Eames T, et al. Split-face comparison of intense pulsed light with shortand long-pulsed dye lasers for the treatment of port-wine stains. Lasers Surg Med. Oct 2010;42(8):720-727. PMID 20886506

4. Klein A, Szeimies RM, Baumler W, et al. Indocyanine green-augmented diode laser treatment of port-wine stains: clinical and histological evidence for a new treatment option from a randomized controlled trial. Br J Dermatol. Aug 2012;167(2):333-342. PMID 22435991

5. Passeron T, Maza A, Fontas E, et al. Treatment of port wine stains with pulsed dye laser and topical timolol: a multicenter randomized controlled trial. Br J Dermatol. Dec 6 2013. PMID 24641096

6. Tremaine AM, Armstrong J, Huang YC, et al. Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod. J Am Acad Dermatol. Apr 2012;66(4):634-641. PMID 22244840

7. Yu W, Ma G, Qiu Y, et al. Prospetive comparison treatment of 595-nm pulsed-dye lasers for virgin port-wine stain. Br J Dermatol. Mar 2015; 172(3): 684-691. PMID 25130205.

Codes

Policy History