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Medical Policy

Policy Num:       02.001.017
Policy Name:     Laser Treatment of Active Acne
Policy ID:          [02.001.017]      [Ar / B / M / P ]       [2.01.69]

Archive

Last Review:       March 23, 2020
Next Review:      Policy Archive
Issue:                   3: 2020

Related Policies: 2.01.44 Dermatologic Applications of Photodynamic Therapy

Laser Treatment of Active Acne

Summary

Acne is a condition of the pilosebaceous follicular glands that affects mainly adolescents and young adults and that can be classified as inflammatory and non-inflammatory.

Acne is characterized by the presence of comedones, nodules and rashes of papules, pustules and nodulocystic lesions. The lesions are found in areas of higher concentration

of sebaceous glands such as face, neck and upper trunk. The four main causal factors are;

1. Sebaceous glandular hyperplasia with excess production of sebum, mediated by androgens.

2. Abnormal follicular keratinization that promotes clogging of the follicles and the formation of comedones.

3. Proliferation of propionibacterium acne (P. acne). Inflammation occurs as a result of P.acnes products.

4. Genetic factors, diet, and stress can contribute to the development and severity of acne.

The treatment consists of good skin care, benzoyl peroxide, antibiotics and retinoids. Active acne must be differentiated from acne scarring, since it represents the residual

damage to the tissue after the inflammation disappears. The pulse laser has been used in the treatment of acne scarring. Recently it has been tried in the treatment of the active

phase of acne. Laser therapy at different levels of radiation has been used to destroy active acne lesions and enlarged sebaceous glands. It is postulated that the laser improves

the injuries of active acne, reducing the presence of P. acnes that contains porphyrins that are destroyed when exposed to specific wave lengths. Laser also has anti-

inflammatory effects and can reduce or limit the healing potential that can occur in severe cases.

The FDA has approved several devices for the treatment of acne:
· Candela Smoothbeam ™
· CoolTouch® use light in the 1320nm band
· Radiancy ClearTouch ™
· MED flash II
· Ellipse I2PL in the band of 590-1200nm (intense pulsed light) and those that emit violet or blue light
· Band of 414nm and pink light
· 633nm band
· Aura ™
· Clearligth
· Dermillume respectively

The indications of each type of light vary according to the type of acne.D

Lasers have been used to treat acne scarring, and may also be useful for active acne. Various types of laser treatments are available, including pulsed and non-pulsed devices, and differing wavelengths of emitted light. Lasers may improve active acne by killing propionibacterium acnes (P. acnes) and/or by
reducing inflammation.

Policy Statements

The treatment of active acne by means of laser therapy is not considered for payment. The pilot studies are small, they are not random, nor controlled. The American Academy of Dermatology believes there are no long-term studies.

Note: This policy does not apply to the treatment of laser acne scarring.

Policy Guidelines

CPT codes 17110-17111 [destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous

vascular lesions] are not specific to acne lesions but would be used for this procedure if it is performed to destroy milia. For other laser treatment of acne, CPT code 17999 would

be the more appropriate code. To identify laser treatments for acne, the CPT code can be coupled with the ICD-9 code of 706.1 (Acne: NOS, vulgaris,

conglobata, cystic, pustular, blackhead, comedo). Note: This policy does not apply to the treatment of acne scarring.

Benefit Application

BlueCard/National Account Issues

Some state or federal mandates (e.g., FEP) prohibit Plans from denying technologies approved by the U.S. Food and Drug Administration (FDA) as investigational. In these

instances, Plans may have to consider the coverage eligibility of FDA-approved technologies on the basis of medical necessity alone. Plans may wish to examine specific

contract language regarding the definitions of cosmetic services to determine whether contract or benefit exclusions may apply to the treatment of active acne. Please refer

to Policy No. 10.01.09 for further discussion on cosmetic/reconstructive services.

Background

Regulatory Status

A number of laser and focused light devices have received marketing clearance for the treatment of acne via the U.S. Food and Drug Administration’s (FDA’s) 510(k)

mechanism. These include lasers that emit light at 1320 nm (Candela Smoothbeam™ and CoolTouch®); intense pulsed light systems, which emit light in the range of 590 to

1200 nm (Radiancy ClearTouch™, MED flash II and Ellispse I 2 PL); pulsed dye lasers (ICN Photonics NLite System); and lasers or high-intensity light devices, which emit violet

or blue (around 414 nm) and red (around 633 nm) light (Aura™, Clearlight and Dermillume). The specific indications for these devices vary; Candela Smoothbeam™ is indicated

solely for the treatment of acne on the back, others are indicated for the treatment of inflammatory acne or for mild to moderate acne with no location specified. In 2006, a

thermal device (ThermaClear™) was cleared for marketing for the “treatment of individual acne pimples in persons with mild to moderate inflammatory acne” in both a

practitioner’s office environment and a consumer home-use environment.

Rationale

An initial literature search of MEDLINE through September 2004 was conducted when the policy was created. Since that time, the policy has been updated regularly with a literature review using MEDLINE; most recently, the literature search was conducted from April 2008 through September 2009. 

Two systematic reviews of light therapies for treatment of active acne were identified. Both reviews included studies on photodynamic therapy, as well as light and laser therapy.

Trials on photodynamic therapy (PDT) will not be discussed further as they are addressed in another policy (2.01.44). Neither review conducted any pooled analyses of laser

treatment studies due to heterogeneity between studies (e.g. different wavelengths of light were used). The two systematic reviews had similar assessments of

the literature. Hamilton and colleagues identified 10 randomized controlled trials comparing light therapy to placebo and 3 RCTs comparing light therapy to topical treatment of

acne. (1) The authors commented that studies of light therapy tended to be small (all had fewer than 50 participants), of short duration and of variable quality, and that a few

compared light therapy to conventional treatment. They concluded: “our review found only limited or no benefit is given by light therapies alone…Further trials comparing light

therapy with usual treatment, using a larger effect size in the power calculations, would be helpful to determine the usefulness of light therapy in treating acne.” The other

systematic review by Haedersdal and colleagues included 11 RCTs on light treatments (other than photodynamic therapy) and stated that that most of the studies had suboptimal

methods. (2) For example, few studies described their randomization method and most had large losses to follow-up without intention to treat analysis. The authors state, “Based

on the present best available evidence, we conclude that optical treatments with lasers, light sources and PDT possess the potential to improve inflammatory acne on a short-

term basis with the most consistent outcomes for PDT. We recommend that patients are informed of the existing evidence, which denotes that optical treatments for acne today

are not included among first-line treatments” There is no separate conclusion focusing on laser therapy. The systematic reviews identified a number of side effects from optical

treatments, and these include pain, erythema, edema, crusting, hyperpigmentation, and pustular eruptions.

Key individual RCTs with at least 40 participants are described as follows:

Seaton et al., 2003: This trial was a double-blind RCT of 41 adults with mild to moderate facial inflammatory acne (i.e., Leeds acne severity score of between 2 and 7). Patients

were randomized to receive a single low fluence pulsed dye laser treatment or sham treatment. At 12 weeks, Leeds acne scores fell from 3.8 to 1.9 in the treatment group and

from 3.6 to 3.5 in the control group. Total lesion counts fell by 53% and 9% and inflammatory lesion counts fell by 49% and 10% in the laser treatment group and control group,

respectively. While the authors reported statistically significant improvements, they concluded that “laser treatment should be further explored as an adjuvant or alternative to

daily conventional pharmacological treatments.” (3) ï‚· Orringer et al., 2004: The article reported on a single-blind, split-face RCT of 40 patients (aged 13 years or older with

a Leeds acne score of 2 or greater) who were randomized to receive either one or two sessions of pulsed dye laser treatment (3 J/cm2 fluence) to half of the face with the

opposite, non-treated side serving as the control. At 12 weeks, changes in lesion counts (including pustules, comedones, macules, cysts, and papules) and mean Leeds acne

scores were not significantly different for the treated versus untreated sides of the face. The authors concluded that “…additional well designed studies are needed before the

use of pulse dye laser becomes a part of acne therapy.” (4) ï‚· Orringer et al., 2007: This RCT assessed the efficacy of a 1320-nm laser (CoolTouch II) in 46 patients in a

split-face design. Laser treatment was given once every 3 weeks, with blinded evaluation by a panel of 3 dermatologists (from photographs taken at 7 and 14 weeks). Thirty

patients completed the 14-week assessment (35% dropout); data were carried forward to adjust  for subjects who may have dropped out of the study due to lack of effect. The

authors report that the treated side remained unchanged at 0.22 cysts (10 total cysts in 46 subjects) while the untreated side increased from 0.27 to 0.70 cysts. Subjective

patient reports (of 37 who completed at least the 7-week assessment; not blinded to treatment) favored the treated side over the control side for a decrease in acne (59%) and

oily skin (54%). No differences were found between the treated and un-treated sides in the number of papules, pustules, open comedones, or closed comedones at 14 weeks.

· Laheta, 2009: This study included 45 patients with mild to moderate acne who were randomly assigned to one of three groups (15 patients per group). Group A received pulsed

dye laser therapy (3 J/cm2 fluence) every 2 weeks for 6 sessions; Group B applied topical treatment with 0.1% tretinoin cream every evening and 5% benzoyl peroxide gel every

morning; and Group C underwent chemical peeling using trichloroacetic acid 25%. An assessor blinded to treatment group evaluated outcomes; 41 patients were included in the

analysis. There was no significant difference between groups in the acne severity score (0=no acne to 10=severe acne) at the end

of the 3-month treatment period. Mean scores were 0.56 ± 0.57 for Group A, 0.65 ± 0.47 for Group B, and 0.68 ± 0.50 for Group C (p=0.38). The analysis of disease severity did

not adjust for baseline scores, and standard deviations were large due to the small number of participants in each group. The degree of clinical response (marked or moderate)

and side effects (trace, mild, or moderate) also did not differ significantly between the three groups. The proportion of patients with moderate side effects was 23% in Group A,

15% in Group B, and 13% in Group C (overall pvalue=0.95). (6)

Population Reference No. 1 Policy Statement

Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser, and

paucity of studies comparing pulsed dye laser with pharmacological treaments, the evidence is insufficient to draw conclusions about the impact

of laser treatments on health outcomes in patients with active acne. Therefore, the technology is considered investigational

Population Reference No. 2 Policy Statement

Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser, and

paucity of studies comparing pulsed dye laser with photodynamic therapy, the evidence is insufficient to draw conclusions about the impact of

laser treatments on health outcomes in patients with active acne. Therefore, the technology is considered investigational

Population Reference No. 3 Policy Statement

Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser, and

paucity of studies comparing pulsed dye laser with ,other light treatments,  the evidence is insufficient to draw conclusions about the impact of

laser treatments on health outcomes in patients with active acne. Therefore, the technology is considered investigational

Population Reference No. 4 Policy Statement

Text

Population Reference No. 5 Policy Statement

Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser, and paucity of

studies comparing pulsed dye laser with ,topical treaments ,  the evidence is insufficient to draw conclusions about the impact of laser treatments on

health outcomes in patients with active acne. Therefore, the technology is considered investigational.

Population Reference No. 6 Policy Statement

Due to the small sample sizes of the published trials, lack of long-term follow-up, small number of studies on any particular type of laser, and

paucity of studies comparing pulsed dye laser with a placebo ,  the evidence is insufficient to draw conclusions about the impact of laser

treatments on health outcomes in patients with active acne. Therefore, the technology is considered investigational

Supplemental Information

Practice Guidelines and Position Statements

American Academy of Dermatology (AAD)

America Academy of Dermatology (AAD): An on-line information sheet endorsed by the AAD states “several laser and light treatments are available to treat acne. Some of these

laser and light treatments target only one factor that causes acne ".

Medicare National Coverage

No national coverage determination

References

1. Hamilton FL, Car J, Lyons C et al. Laser and other light therapies for the treatment of acne vulgaris:
systematic review. Br J Dermatol 2009; 160: 1273-1285.
2. Haedersdal M, Togsverd-Bo K, Wiegell SR et al. Long-pulsed dye laser versus long-pulsed dye laserassisted photodynamic therapy for acne vulgaris: a randomized controlled trial. J Am Acad Dermatol
2008; 58(3):387-94.
3. Seaton ED, Charakida A, Mouser PE et al. Pulsed-dye laser treatment for inflammatory acne vulgaris:
randomized controlled trial. Lancet 2003; 362(9393):1347-52.
4. Orringer JS, Kang S, Hamilton T et al. Treatment of acne vulgaris with a pulsed dye laser: a
randomized controlled trial. JAMA 2004; 291(23):2834-9.
5. Orringer JS, Kang S, Maier L et al. A randomized, controlled, split-face clinical trial of 1320-nm Nd:YAG
laser therapy in the treatment of acne vulgaris. J Am Acad Dermatol 2007; 56(3):432-8.
6. Laheta TM. Role of the 585-nm pulsed dye laser in the treatment of acne in comparison with other
topical therapeutic modalities. J Cesmetic Laser Ther 2009; 11: 118-124. 

7. http://www.skincarephysicians.com/acnenet/PhysicalProcedures.html. Last accessed October 2009.

Codes

Appplicable Modifiers

Policy History