Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2003046
Category:	Surgery
Initiated:	July 2003
Last Review:	February 2024

Laser Treatment of Congenital Port Wine Stain Hemangiomas and Burn Scars

Description:

Port wine stains are common vascular malformations that start as pink macules and, if untreated, tend to become darker and thicker over time. They usually occur on the face and neck, but can be located elsewhere on the body. Treatment with lasers (including pulsed dye lasers, Alexandrite, Nd:YAG lasers and intense pulsed light [IPL]) is proposed.

Port wine stains are the most common of the vascular malformations, affecting approximately 3 in 1,000 children. They are composed of networks of ectatic 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.

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 (585-600 nm) 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 PDL are the long-pulsed 1,064 nm Nd:YAG and 755 nm pulsed Alexandrite lasers. The 1,064 nm Nd:YAG laser requires a substantial degree 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. Intense pulsed light (IPL) devices emit polychromatic high-intensity pulsed light. Pulse duration is in the millisecond range, and devices use an emission spectrum ranging from 500 to 1,400 nm. Compared to other types of lasers, IPL devices include both the oxyhemoglobin selective wavelengths emitted by PDL systems and longer wavelengths that allow deeper penetration into the dermis.

Regulatory Status

Several 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. In addition, the Cynergy Multiplex Laser (Cynosure), a combined Nd:YAG and pulsed dye laser was approved by the FDA in 2005 for treatment of benign vascular and vascular dependent lesions, including port wine stains.

In 2003, the Lumenis family of intense pulsed light systems was approved by the FDA; indications for use include dermatologic applications. Subsequently, the NannoLight intense pulsed light system (Global USA Distribution) was approved by the FDA in 2008 and the Mediflash3 and Esterflash3 systems (Dermeo) were approved in 2010 for indications specifically including treatment of port wine stains.

Policy/
Coverage:

Effective May 15, 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Laser treatment meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of congenital hemangiomas or port wine stains (cutaneous vascular proliferative lesions) of the face and neck.

Fractional ablative carbon dioxide laser fenestration of a burn scar or traumatic scar meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and will be approved for 2 sessions when:

There is documented evidence of significant functional impairment related to the scar (i.e., limited movement); and
The treatment can be reasonably expected to improve the functional impairment: and
The individual has tried at least one other scar revision intervention (e.g., silicone gel or sheeting, or pressure garments); and
No more than 5 sites per treatment session are to be treated; and
Less than or equal to 3% BSA (adults).

Continued treatment of fractional ablative carbon dioxide laser fenestration of a burn scar or traumatic scar for up to a total of 5 treatment sessions to the same skin surface area meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when:

Submission of medical records document 50% improvement after the first 2 treatment sessions for each lesion.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Fractional carbon dioxide (CO2) laser therapy (eg DeepFX™ and ActiveFX™) for any indication not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, fractional carbon dioxide (CO2) laser therapy (eg DeepFX™ and ActiveFX™) for any indication not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Fractional ablative carbon dioxide laser fenestration when performed in the absence of a significant functional impairment with intent to change a physical appearance that would be considered within normal human anatomic variation including but are not limited to, enhancing the appearance of the upper layer of the skin as a result of acne, acne scars, uneven pigmentation or wrinkles is considered cosmetic. Cosmetic services are considered a contract exclusion in most member benefit contracts.

Effective January 2019 through May 14, 2022

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Laser treatment meets primary coverage criteria for effectiveness for the treatment of congenital hemangiomas or port wine stains (cutaneous vascular proliferative lesions) of the face and neck.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors does not meet member benefit certificate primary coverage criteria.

Fractional carbon dioxide (CO2) laser therapy (eg DeepFX™ and ActiveFX™) for the treatment of burn scars does not meet member benefit certificate primary coverage criteria.

For members with contracts without primary coverage criteria, fractional carbon dioxide (CO2) laser therapy (eg DeepFX™ and ActiveFX™) for the treatment of burn scars is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to January 2019

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Laser treatment meets primary coverage criteria for effectiveness for the treatment of congenital hemangiomas or port wine stains (cutaneous vascular proliferative lesions) of the face and neck for a child 12 years of age or younger.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors does not meet member benefit certificate primary coverage criteria.

Fractional carbon dioxide (CO2) laser therapy (eg DeepFX™ and ActiveFX™) for the treatment of burn scars does not meet member benefit certificate primary coverage criteria.

Effective Prior to May 2018

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors does not meet member benefit certificate primary coverage criteria.

Effective Prior to September 2015

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors does not meet member benefit certificate primary coverage criteria.

Effective prior to July 2014

Rationale:

Huikeshoven and colleagues reported color measurements at 10 years in 51 patients and compared that to a measurement done after an average of five treatments. On average, the stain measured at follow-up was significantly darker than when measured after five treatments but still significantly lighter than the measurement before treatment. Fifty-nine percent of these patients reported the stain was unchanged and 35% thought it had become darker.

2011 Update

This policy is being updated with a literature search conducted through March 2011. Following is a summary of the key literature to date on laser treatment of port wine stains.

A systematic review published in 2005 identified 71 articles on pulsed dye laser (PDL) treatment for port-wine stains (Smit, 2005). 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 an approximate 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.

Recent review articles affirm that the PDL is the standard treatment for port wine stains. Stier and colleagues stated in 2008 that the optimal parameter setting for PDLs is unclear (Stier, 2008). 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. Stier’s 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. In 2010, Klein and colleagues agreed that PDLs are still the treatment of choice for macular port wine stains but noted that approximately 30% of patients are treatment-resistant (Klein, 2011). The Klein et al. article stated that, in general, the parameters used are 585-600 nm wavelengths (the same as the Stier et al. article), 5-18 J/cm2 fluence, 0.45-10-ms pulse duration, and a 5-10mm spot size.

Cordisco discussed options for patients who do not respond to treatment with PDLs (Cordisco, 2009). The author commented that it is not currently clinically possible to define criteria that will predict who will respond to PDL treatment. Other interventions have been proposed for patients with treatment-resistant port wine stains. These include combined pulsed dye and Nd:YAG laser treatment, and combined PDL and angiogenesis inhibitor treatment. One prospective study that evaluated combined laser treatment was identified. In 2009, Alster and Tanzi published a study with 25 patients with incomplete clearance after at least 11 PDL treatments (Alster, 2009). They received treatment with the Cynergy device (combination of 595 PDL and 1064 Nd:YAG laser). Nineteen patients had port wine stains in a trigeminal location, and 6 had extremity involvement. Patients received a mean of 3.8 Cynergy treatments on the face and 4.9 on the extremities. Moderate clinical improvement (25-50%) was observed in 12 (48%) patients, and mild improvement (1-25%) was observed in 13 (52%) patients.

Several small split-side controlled studies have compared outcomes of intense pulsed light (IPL) and PDL treatment of port wine stains. In 2008, Faurshou and colleagues in Denmark published a study with 20 patients with port wine stains (Faurshou, 2009). Port wine stains were on the face (n=15), trunk (n=4), or extremities (n=1). Eight (40%) had previously untreated lesions, and the remainder were previously treated, but types of lasers not under investigation in the study. Patients received one treatment with a PDL on a randomly selected side of the lesion (left/lower or right/upper) and IPL treatment on the other side. Blinded assessment 12 weeks post-treatment found a median of 65% percentage lightening on the PDL side and 30% on the IPL side (p<0.0003). Fifteen (75%) of 20 patients had more than 70% lightening with PDL treatment compared to 6 (30%) in the IPL group; this difference was also statistically significant, p=0.014. A 2010 study in Germany by Babilas and colleagues was a split-face comparison of PDLs and IPL treatment in 25 patients; 11 (40%) had previously untreated port wine stains, and the other 14 had received previous laser treatment. (7) Port wine stains were located in the face and neck region in 18 patients, the trunk in 3 patients and the extremities in 4 patients. The previously untreated patients were treated with IPL, short-PDL (585 nm and 0.45 millisecond pulse duration), and long-PDL (584-600 nm and 1.5 millisecond pulse duration). Patients who previously failed either short- or long-PDLs did not receive that type of treatment. Blinded outcome assessment was done 6 weeks after treatment. In the treatment-naïve group, assessors rated lightening as excellent (at least 75%) or good (51-75%) in at least one test spot in 7 of 11 (64%) patients after IPL treatment, 5 of 11 (45%) after long-PDL and 1 of 11 (9%) after short-PDL (between group p-value was not reported). In the group that had been previously treated, lightening was rated as excellent or good in at least one test spot in 4 of 14 (29%) patients after IPL treatment, 1 of 14 (7%) after long-PDL treatment, and 0 (0%) after short-PDL treatment. These small studies had mixed findings and do not provide conclusive evidence that one type of laser is superior to the other.

No prospective controlled studies that evaluate combined treatment with lasers and photodynamic therapy or topical angiogenesis inhibitors were identified.

Summary

Studies have generally found that laser treatment can be effective at lightening port wine stains. The preponderance of evidence is on the pulsed-dye laser; there is insufficient evidence from comparative studies that one type of laser results in more lightening than another. There is insufficient evidence that lasers combined with another treatment e.g. photodynamic therapy or topical angiogenesis inhibitors, is superior to laser treatment alone.

2012 Update

A literature search was conducted using the MEDLINE database through June 2012. There was no new literature identified that would prompt a change in the coverage status.

In 2011, a Cochrane review of trials on light or laser sources for treating port-wine stains was published by Faurschou and colleagues (Faurschou, 2011). The review included randomized controlled trials (RCTs) comparing any laser or light source to any comparison intervention. Five RCTs with a total of 103 participants met inclusion criteria. The investigators reported that interventions and outcomes were too heterogenous for a meta-analysis of study findings. All studies used a within-participant (e.g., split-side) design and none of them included a sham treatment or no treatment group. Interventions in all of the trials were between 1 and 3 treatment sessions and all trials followed patients for less than 6 months’ follow-up. A primary efficacy outcome of the review was reduction in redness; investigators judged that a reduction of more than 20% would represent a clinically relevant effect. In all of the 5 trials, treatment with the pulsed dye laser (PDL) resulted in more than 25% reduction in redness in 50-100% of participants, depending on setting of the laser device. In addition, intense pulsed light (IPL) and the Nd:YAG laser also led to a reduction in redness in 1 trial each. The trials found that long-term adverse effects of laser and light treatment were rare; only 1 participant in 1 trial experienced scarring of the skin and this person had a too-high dose of the Nd:YAG laser. The authors concluded that the evidence supports the use of the PDL as the treatment of choice for port-wine stains.

2013 Update

A literature search conducted using the MEDLINE database through June 2013 did not reveal any new information that would prompt a change in the coverage statement. One RCT was identified. In 2012, Klein and colleagues in Germany published findings of an RCT evaluating treatment with a diode laser augmented by the dye indocyanine green (Klein, 2012). The study included 31 patients with port wine stains. Two areas of 2 by 2 cm were selected in each patient’s port wine stain. The areas were randomly assigned to receive treatment with a PDL or with an indocyanine green-augmented diode laser (ICG + DL). The cosmetic appearance of the lesions was assessed using a 5-point Likert-type scale with 0=no clearance to 4=excellent clearance. Three months after treatment, the mean investigator-rated clearance score was 0.89 (standard deviation [SD]: 0.99) for lesions receiving PDL treatment and 1.30 (SD: 1.29) for lesions receiving ICG + DL treatment. The difference in scores between groups was not statistically significant, p=0.11. At 3 months, patients rated the clearance level as a mean of 0.89 (SD: 0.88) after PDL treatment and 1.71 (SD: 1.24) after ICG + DL, p=0.004. Two patients in the diode laser treatment group experienced adverse events. There was one case of site-specific pain during ICG + DL treatment (8 on a 10-point scale) and 1 case of an atrophic scar measuring 5 mm in diameter. Other side effects were burning (PDL: 58%, ICG + DL: 68%), edema (PDL: 3%, ICG + DL: 10%) and purpura (PLD: 71%, ICG + DL, 42%).

2014 Update

A literature search conducted through June 2014 did not identify any new information that would prompt a change in the coverage statement.

Two RCTs on laser treatment in combination with topical angiogenesis inhibitors were identified, and these trials had mixed findings. A 2013 RCT by Passeron et al included 22 children between the ages of 6 months and 18 years who had facial port wine stains no more than 100cm2 (Passeron, 2013). Patients were randomized to receive PDL alone or laser followed by topical timolol. All patients received 3 laser sessions, with a month between sessions. For patients in the combination treatment group, timolol gel was applied twice daily beginning on the day of the first laser treatment and continuing until 15 days after the third and final treatment. Blinded evaluation of patients occurred at baseline and 1 month after the third laser session. In an intention-to-treat analysis, there was no statistically significant difference between groups in the clinical success rate of the 2 treatments, as measured by an investigator global assessment variable. This variable ranged from -1 (worsening) to 4 (complete clearance). A score of 3 (marked improvement) or 4 (complete clearance) was given to 1 of 10 patients treated with laser and 2 of 12 patients treated with combination therapy (p=1.0).

A 2012 study by Tremaine et al evaluated PDL treatment with and without the addition of imiquimod cream (Tremaine, 2012). The study included 24 subjects with port wine stains. All patients initially received 1 session of laser treatment. Five patients enrolled in the study twice, with a washout period of at least 4 weeks before re-enrollment. Patients were randomized to receive additional treatment with either 5% imiquimod cream or placebo cream, to be applied 3 times a week for 8 weeks, beginning the day following laser treatment. Chromameter measurements were taken at baseline and at 8 weeks after laser treatment. The primary outcomes were change in erythema (defined as red/green color saturation with values ranging from +60 green to -60 red) and overall change in 3 color dimensions (reflected light intensity, green/red color saturation, and blue/yellow color saturation). The mean change (SD) in erythema was 0.43 (1.63) for the laser plus placebo sites and 1.27 (1.76) for the laser plus imiquimod sites. The difference between groups was statistically significant (p=0.03) and favored combined treatment. Similarly, the mean change (SD) in overall color was 2.59 (1.54) for laser plus placebo and 4.08 (3.39) for laser plus imiquimod (p=0.04).

There is insufficient evidence that adding topical angiogenesis inhibitor to laser therapy results in better outcomes than lasers alone. There was 1 positive RCT and 1 negative RCT. No comparative studies were identified on lasers combined with any other treatments. A statement addressing the use of treatment of lasers in combination with photodynamic therapy or topical angiogenesis inhibitors was added to the policy statement.

2016 Update

A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement.

2018 Update

Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Several journal articles have been published on the use of fractional carbon dioxide laser in the treatment of burn scars. No randomized control trials studying the effectiveness of fractional CO2 laser for the treatment of burn scars were identified.

Hultman et al (2014) performed a prospective “before-after” study that examined the long-term impact of laser therapy to treat burn patients with hypertropic scars. A total of 147 burn patients (mean age, 26.9 years with hypertrophic burn scars involving a mean total body surface area, 16.1%) received more than 415 laser sessions 16 months after burn injury. Of the 415 laser sessions, 327 sessions used pulsed dye laser (PDL) and 139 used a fractional ablative CO2 laser modality such as UltraPulse in Active FX or Deep FX. Pulsed-dye laser was used for pruritus and erythema; fractional CO2 laser was used for stiffness and abnormal texture. Outcomes included (1) Vancouver Scar Scale (VSS), which documents pigmentation, erythema, pliability, and height, and (2) University of North Carolina "4P" Scar Scale (UNC4P), which rates pain, pruritus, paresthesias, and pliability. Laser treatments produced rapid, significant, and lasting improvements in hypertrophic scar. Provider-rated VSS dropped from 10.43 [standard deviation (SD) 2.37] to 5.16 (SD 1.92), by the end of treatments, and subsequently decreased to 3.29 (SD 1.24), at a follow-up of 25 months. Patient-reported UNC4P fell from 5.40 (SD 2.54) to 2.05 (SD 1.67), after the first year, and further decreased to 1.74 (SD 1.72), by the end of the study period.

Poetschke et al (2017) prospectively studied the effects of a single treatment session of fractional ablative CO2 laser fenestration in 10 adults (three male and seven female with an average age of 39.3 years) with widespread hypertrophic burn scars that were older than 18 months. Documentation was based on modern scar scales and questionnaires, such as the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and Dermatology Life Quality Index (DLQI), as well as clinical measurements (PRIMOS, Cutometer). Over the course of 6 months after treatment, VSS and POSAS scores showed significant improvement. Quality of life rating according to the DLQI also improved. In the treated scars, surface relief improved significantly, and scar firmness could be reduced by 30% after one treatment session. The researchers concluded that fractional ablative CO2-laser treatment was a safe and efficacious option for the treatment of hypertrophic burn scars that demonstrated significant improvement after a single course of treatment.

Gold et al (2014) on behalf of the International Advisory Panel on Scar Management published an updated set of practical evidence-based guidelines for the management of hypertrophic scars and keloids. These guidelines were developed by an international group of 24 experts from a wide range of specialties who updated their initial 2002 review of emerging clinical data, new treatment options, and technical advances. Monstrey et al (2014) also published a review of the Gold et al (2014) guidelines. An initial set of strategies to minimize the risk of scar formation is applicable to all types of scars and is indicated before, during and immediately after surgery. In addition to optimal surgical management, this includes measures to reduce skin tension, and to provide taping, hydration and ultraviolet (UV) protection of the early scar tissue. Silicone sheeting or gel is universally considered as the first-line prophylactic and treatment option for hypertrophic scars and keloids. The efficacy and safety of this gold-standard, non-invasive therapy has been demonstrated in many clinical studies. Laser therapy is another invasive option which can be used to treat the surface texture of abnormal scars and may also be suitable for the treatment of residual redness, telangiectasias or hyperpigmentation. Gold et al (2014) and Monstrey et al (2014) both agree that ablative and non-ablative fractional lasers are the focus of several research studies, and that the evidence is generally favorable for fractional CO2 laser therapy as a prevention and treatment of hypertrophic scars. However, more evidence on the choice of the laser device as well as the laser settings and treatment schedules is needed to establish its clinical effectiveness in treating hypertrophic scars.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2019. No new literature was identified that would prompt a change in the coverage statement.

2020 Update

A literature search was conducted through April 2020. There was no new information identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2022. The key identified literature is summarized below.

Fractional Ablative CO2 Lasers and Laser Fenestration for Burn or Traumatic Scars

The optimal approach for treatment of hypertrophic burn scars depends on the degree of tension on the burn wound margin and involved surface area. Laser therapy can produce microscopic patterns of thermal injury in the dermis, which stimulates the complex process of tissue remodeling in scar management. Ablative (and nonablative) fractional lasers produce numerous nonselective, microscopic vertical zones of thermal damage, referred to as microscopic thermal zones (MTZs), throughout the epidermis and dermis. Fractional ablative lasers (including CO2 lasers) create zones of ablation at variable depths of the skin with subsequent induction of wound healing and collagen remodeling (Waibel, 2013). The surrounding undamaged skin adjacent to a MTZ acts as a reservoir of viable tissue, allowing the rapid repopulation of the epidermis. A skin tightening effect also occurs following treatment with fractional ablative lasers; both immediate and delayed collagen contraction and collagen remodeling may contribute to improvement in skin laxity.

Fractional ablative CO2 laser fenestration is a type of laser technique used to treat mature hypertrophic and contracted burn or traumatic scars that result in significant symptoms (such as pain) or functional impairment (Anderson, 2014). The efficacy and safety of fractional ablative CO2 laser fenestration in the management of hypertrophic burn or traumatic scars has been evaluated in an observation study, uncontrolled prospective studies, and numerous retrospective case series (Qu, 2012; Shumaker, 2012; Waibel, 2013).

Poetschke and colleagues prospectively studied the effects of a single treatment session of fractional ablative CO2 laser fenestration in 10 adults (average age, 39.3 ± 15.3 years) with widespread hypertrophic burn scars older than 1.5 years (Poetschke, 2017). The mean scar age was 12.45 (± 17.18) years with a range of 2.5 to 56 years. A total of 60% of participants had previously undergone other forms of scar therapy including scar gels and sheets, microneedling, massages, pressure garments, intralesional corticosteroid injections, and surgery. Similarly scarred skin areas were assessed, and 2 were selected of approximately 10 cm by 10 cm with 1 area treated and the other area left untreated as a control. Treatment effects, including scarring, quality of life, and treatment progress were evaluated using the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and Dermatology Life Quality Index (DLQI) clinical questionnaires. Measurements of skin relief and pliability in the treated and untreated scars were taken once before treatment, and at 1, 3, and 6 months after a single treatment using a noninvasive high-resolution imaging system and other noninvasive measurement devices. Over the course of 6 months after treatment, VSS and POSAS scores showed significant improvement in the rating of scar parameters, as did the quality of life rating according to the DLQI. The overall VSS score decreased from an initial rating of 6.8 to 2.2 at 6 months (p<0.0001). Pliability improved with a pretreatment VSS of 3.2 to 1.3 at 6 months (p=0.004). The POSAS Observer Scale and Overall Opinion scores dropped from pretreatment to 6 months following treatment (23.60 to 13.30 [p=0.014] and 5.2 to 2.60 [p=0.003], respectively), with the largest changes observed in the categories pliability (4.6 to 2.6; p=0.0115), surface area (3.8 to 1.8; p=0.013), and thickness (3.9 to 2.2; p=0.019). Objective clinical measurement of scar surface irregularities (through the parameters Smax and Sz) indicated significant improvement in treated scars over the course of 6 months, with the most improvement occurring 1 to 3 months postoperatively. Throughout the study, none of the participants experienced severe side effects after receiving laser treatment. Treatment pain was reduced with use of local topical anesthesia.

Issler-Fisher and colleagues prospectively evaluated the efficacy and safety of fractional ablative CO2 laser treatment in severe burn scars with structural changes (that is, atrophic, hypertrophic, and keloid scars) (Issler-Fisher, 2017). A total of 47 individuals (ages 16-80) with 118 severe burn scars completed one UltraPulse® Encore CO2 (Lumenis Ltd., Yokneam, Israel; Lumenis Inc. USA, San Jose, CA) laser treatment in the Active FX and Deep FX modes, with (n=6) or without (n=41) other simultaneously performed surgical reconstructive procedures (such as contracture release with Z-plasty). Subjective parameters collected included assessment of neuropathic pain, pruritus, and quality of life using the Burns Specific Health Scale (BSHS-B). For treatment effect analysis, individuals were stratified according to scar maturation status (> or < 2 years after injury). At a median follow-up of 55 days after laser treatment, all analyzed objective parameters decreased significantly, including intra-subject normalized scar thickness decreasing from a median of 2.4 mm to 1.9 mm (p<0.001), with a concomitant drop in VSS score from a median of 7 to 6 (p<0.001). The Observer Scar Assessment Score of the POSAS (POSAS-O; maximal score 60) decreased from a median of 29.0 to 21.0 (p<0.001, 47 individuals, 118 scars), and the overall POSAS-O (maximal score 10) decreased from 5.0 to 4.0 (p<0.001, 46 individuals, 116 scars). All of the identified changes following laser treatment remained significant irrespective of scar maturation status. Quality of life increased significantly by 15 points (median 120 to 135; p<0.001). A significant reduction was reported in both pain and pruritus. No wound infections occurred following laser treatment.

Zadowski and colleagues conducted an observational study of 47 children (ages 6 to 16 years; mean age, 10.5 years) with hypertrophic burn scars treated with fractional ablative CO2 laser fenestration (Zadowski, 2016). The average time from initial burn to treatment was 7.5 ± 2 years. The average burned total body surface area was 8.8% with a minimum VSS score of 4 points. A total of 57 laser sessions were performed; 10 children with extensive burn scars were treated twice. Treatment outcomes were reported as changes in VSS score at 1, 4, and 8 months post treatment and ultrasound evaluation of scar thickness before and after treatment. The greatest change in total VSS score in area 1 by physician evaluation was obtained at 1 month following treatment (2.05 points difference; average 7.23 points before to 5.18 points 1 month post treatment). Improvement in 3 of 4 VSS parameters was observed, including pigmentation (81% of assessed area 1 and no worsening), height (88% of assessed areas; p<0.05), and pliability of scarring (98%; p<0.05). The most common adverse effect was erythema at 1 and 4 months post treatment.

Hultman and colleagues performed a prospective study at a single center evaluating 147 individuals with hypertrophic burn scars involving a mean body surface area of 16% (Hultman, 2013). Procedures were performed more than 6 months after burn injury and repeated monthly. The overall treatment algorithm included four laser treatment modalities: pulsed dye laser (PDL), fractional ablative CO2 laser (UltraPulse in Active FX and Deep FX modes to treat abnormal texture, thickness, and stiffness of the more mature scar), intense pulsed light (IPL)/neodymium-doped:YAG (Nd:YAG) laser, and Alexandrite laser procedures. A total of more than 415 sessions (2.8 sessions/individual), including PDL (n=327) and CO2 laser treatments (n=139) were administered to flame burns (n=75), scald injury (n=37), and other burns (n=35). Treatments occurred 16 months (median) and 48 months (mean) after burn injury. Functional outcomes were assessed at baseline, immediately before the first session, and 4 to 6 weeks later (at the time of the next session) with the VSS and a subjective, self-reported University of North Carolina (UNC) designed “4P’’(UNC4P) Scar Scale which assessed 4 components of the burn scar: pruritus, paresthesias, pain, and pliability. The range of scores for the UNC4P was 0 to 12, with higher scores associated with more morbidity. Mean length of follow-up was 4.7 months. Outcomes were reported as a significant decrease in VSS score from 10.4 to 5.2 (p<0.0001). The participant-reported UNC4P Scar Scale score decreased from 5.4 to 2.1 (p<0.0001). The largest decline in both VSS and UNC4P scores occurred after the first laser session. VSS and UNC4P scores decreased significantly after 1 session from 10.43 to 6.67 and 5.40 to 2.89, respectively (p<0.0001). Subsequent sessions, were reported (in composite) as yielding statistically significant reductions in scar scores. Adverse events or outcomes representing 12.9% of participants, 4.6% of sessions, and 3.9% of all treatments included hypopigmentation (n=8), moderate to severe blistering (n=4), post-inflammatory hyperpigmentation (n=3), intraoperative arrhythmia (n=1), postoperative cellulitis of concurrent adjacent tissue rearrangement (n=1), superficial yeast infection of burn scar (n=1), and oral herpes simplex infection (n=1). Hultman and colleagues reported on long-term follow-up (mean, 30.7 months) of the original study participants from 2011 (Hultman, 2014). Using only data from participants seen in 2013 (n=35), the long-term cohort had significant improvement in VSS (10.28 to 5.31, p<0.001) and UNC4P scores (5.18 to 1.93, p<0.001) at 5-month follow-up. At 30-month follow-up, provider-rated VSS scores continued to drop to 3.29 (p<0.001), while UNC4P remained stable at 1.74 (no significant change). In summary, long-term follow-up participants with hypertrophic burn scars who underwent laser treatments had both early and late improvement in VSS and UNC4P scores, but also had more treatments than the cohort with only short-term follow-up.

Other Considerations

A consensus report published by eight independent, self-selected academic and military dermatology and plastic surgery physicians with extensive experience in the use of lasers for scar treatment concluded (Anderson, 2014):

Ablative fractional lasers typically produce the greatest improvement for hypertrophic and contracted scars, with or without the addition of intralesional or topical medications (eg, corticosteroids or antimetabolites)…Current ablative fractional laser (AFL) devices have a significantly greater potential depth of thermal injury compared with non-ablative fractional laser (NAFL) devices (approximately 4.0 and 1.8 mm, respectively). Therefore, the AFL may prove more effective for thicker scars and for scars associated with restriction. Our consensus is that an appropriate degree of surrounding thermal coagulation around the ablated column appears to facilitate the subsequent remodeling response.

The optimal time to begin fractional laser treatment is undetermined. A minimum treatment interval of 1 to 3 months between fractional laser treatments is suggested, and the treatments are continued until a therapeutic plateau or treatment goals are achieved.

International guidelines for the prevention and treatment of pathologic scarring based upon expert consensus include the following recommendations (Gold, 2014):

Immature or linear hypertrophic erythematous scars resulting from surgery or trauma that present with persistent erythema for more than 1 month despite preventive treatment with silicone gel or sheeting, hypoallergenic paper tape, or onion extract preparations may be treated with pulsed dye laser (PDL) once monthly for 2 to 3 months. Fractional laser therapy is reserved for scars that are refractory to PDL.
Widespread hypertrophic burn scars that failed to improve with treatment with silicone gel or sheeting, pressure garments, and/or onion extract preparations for 8 to 12 weeks may be treated with fractional laser therapy.

The optimal interval between different laser treatments has not been established (Anderson, 2014). Intervals ranging from 4 weeks to 2 to 3 months have been used, with most studies suggesting 6 weeks as the optimal interval.

Fractional ablative lasers have a reported improved adverse effect profile compared with nonfractional ablative devices, however, delayed wound healing, post-inflammatory hyperpigmentation, scarring, and ulceration, particularly in areas of thinner skin and decreased adnexal structures such as the neck, have been reported (Lee, 2011; Ozog, 2013). Relative contraindications to fractional ablative laser treatment include fresh healing wounds with unstable epidermal coverage in the first 1 to 3 months after injury and active infection (Anderson, 2014). In addition, a history of herpes simplex virus infection should prompt prophylactic antiviral treatment before offering laser therapy.

Jin and colleagues performed a meta-analysis of 28 clinical trials with 919 subjects evaluating the response rate of various laser therapy in hypertrophic scar and keloid management (Jin, 2013). The overall response rate for laser therapy was 71% for scar prevention, 68% for hypertrophic scar treatment, and 72% for keloid treatment. The 585/595-nm pulsed-dye laser and 532-nm laser subgroups yielded the best responses among all laser systems. Recurrence or progression of treated scars was not reported in any of the included trials, further trials that record this data are needed.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.

2024 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

0479T	Fractional ablative laser fenestration of burn and traumatic scars for functional improvement; first 100 cm2 or part thereof, or 1% of body surface area of infants and children
0480T	Fractional ablative laser fenestration of burn and traumatic scars for functional improvement; each additional 100 cm2, or each additional 1% of body surface area of infants and children, or part thereof (List separately in addition to code for primary procedure)
17106	Destruction of cutaneous vascular proliferative lesions (eg, laser technique); less than 10 sq cm
17107	Destruction of cutaneous vascular proliferative lesions (eg, laser technique); 10.0 to 50.0 sq cm
17108	Destruction of cutaneous vascular proliferative lesions (eg, laser technique); over 50.0 sq cm

References:

Alster TS, Tanzi EL.(2009) Combined 595-nm and 1064-nm laser irradiation of recalcitrant and hypertrophic port-wine stains in children and adults. Dermatol Surg 2009; 35:914-9.

Anderson RR, Donelan MB, Hivnor C, et al.(2014) Laser treatment of traumatic scars with an emphasis on ablative fractional laser resurfacing: consensus report. JAMA Dermatol. 2014; 150(2):187-193.

Babilas P, Schreml S, Eames T et al.(2010) Split-face comparison of intense pulsed light with short- and long-pulsed dye lasers for the treatment of port-wine stains. Lasers Surg Med 2010; 42:720-7.

Cordisco MR.(2009) An update on lasers in children. Curr Opin Pediatr 2009; 21(4):499-504.

Faurschou A, Olesen AB, Leonardi-Bee J et al.(2011) Lasers or light sources for treating port-wine stains. Cochrane Database Syst Rev 2011; (11):CD007152.

Faurshou A, Togsverd-Bo K, Zachariae C et al.(2009) Pulsed dye lasers vs. intense pulsed light for port-wine stains. A randomized side-by-side trial with blinded response evaluation. Br J Dermatol 2009; 160:359-64.

Foerster V, Murtagh J, Fiander M.(2007) Pulsed dye laser therapy for port wine stains (Technology Report number 78). Ottawa: Canadian Agency for Drugs and Technologies in Health; 2007.

Gold MH, Berman B, Clementoni MT, et al.(2014) Updated international clinical recommendations on scar management: Part 1 -- evaluating the evidence. Dermatol Surg. 2014;40(8):817-824.

Higuera S, Gordley K, et al.(2006) Management of hemagiomas and pediatric vascular malformations. J Craniofac Surg, 2006; 17:783-9.

Huikeshoven M, Koster PH, et al.(2007) Redarkening of port-wine staines 10 years after pulsed-dye-laser treatment. NEJM, 2007; 356:1235-40.

Hultman CS, Edkins RE, Wu C, et al.(2013) Prospective, before-after cohort study to assess the efficacy of laser therapy on hypertrophic burn scars. Ann Plast Surg. 2013; 70(5):521-526.

Hultman CS, Friedstat JS, Edkins RE, et al.(2015) Laser resurfacing and remodeling of hypertrophic burn scars: the results of a large, prospective, before-after cohort study, with long-term follow-up. Ann Surg. 2014; 260(3):519-529; discussion 529-532. Erratum in: Ann Surg. 2015; 261(4):811

Issler-Fisher AC, Fisher OM, Smialkowski AO, et al.(2017) Ablative fractional CO(2) laser for burn scar reconstruction: an extensive subjective and objective short-term outcome analysis of a prospective treatment cohort. Burns. 2017; 43(3):573-582.

Jin R, Huang X, Li H, et al.(2013) Laser therapy for prevention and treatment of pathologic excessive scars. Plast Reconstr Surg. 2013; 132(6):1747-1758.

Klein A, Baumler W, Landthaler M et al.(2011) Laser and IPL treatment of port-wine stains: therapy options, limitations and practical aspects. Lasers Med Sci 2011. (Epub ahead of print)

Klein A, Szeimies RM, Baumler W et al.(2012) 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 2012; 167(2):333-42.

Kono T, Groff WF, Sakurai H.(2006) Treatment of port wine stains with the pulse dye laser. Ann Plast Surg, 2006; 54:460-3.

Lee SY, Park J.(2015) Postoperative electron beam radiotherapy for keloids: treatment outcome and factors associated with occurrence and recurrence. Ann Dermatol. 2015; 27(1):53-58.

Monstrey S, Middelkoop E, Vranckx JJ, et al.(2014) Updated scar management practical guidelines: Non-invasive and invasive measures. J Plast Reconstr Aesthet Surg. 2014;67(8):1017-1025.

Ozog DM, Liu A, Chaffins ML, et al.(2013) Evaluation of clinical results, histological architecture, and collagen expression following treatment of mature burn scars with a fractional carbon dioxide laser. JAMA Dermatol. 2013; 149(1):50-57.

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

Poetschke J, Dornseifer U, Clementoni MT, et al.(2017) Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. Lasers Med Sci. 2017; 32(5):1031-1040.

Poetschke J, Dornseifer U, Clementoni MT, et al.(2017) Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. Lasers Med Sci. 2017; 32(5):1031-1040.

Qu L, Liu A, Zhou L, et al.(2012) Clinical and molecular effects on mature burn scars after treatment with a fractional CO2 laser. Lasers Surg Med. 2012; 44(7):517-524.

Shumaker PR, Kwan JM, Landers JT, Uebelhoer NS.(2012) Functional improvements in traumatic scars and scar contractures using an ablative fractional laser protocol. J Trauma Acute Care Surg. 2012; 73(2 Suppl 1):S116-S121.

Smit JM, Bauland CG, et al.(2005) Pulsed dye laser treatment, a review of indicationsand outcome based on published trials. Br J Plast Surg, 2005:58:981-7.

Soueid A, Waters R.(2006) Re-emergence of port wine stains following treatment with flashlamp-pumped dye laser 585 nm. Ann Plast Surg, 2006; 57:260-3.

Stier MF, Glick SA, Hirsch RJ.(2008) Laser treatment of pediatric vascular lesions: Port wine stains and hemangiomas. J Am Acad Dermatol 2008; 58(2):261-85.

Tomson N, Lim SP, et al.(2006) The treatment of port-wine stains with the pulsed-dye laser at 2-week and 6-week intervals: a comparative study. Br J Dermatol, 2006; 154:676-9.

Tremaine AM, Armstrong J, Huang YC et al.(2012) Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod. J Am Acad Dermatol 2012; 66(4):634-41.

Waibel JS, Wulkan AJ, Shumaker PR.(2013) Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013; 45(3):135-140.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.