Fractional Carbon Dioxide (CO2) Laser Ablation Treatment of Hypertrophic Scars or Keloids for Functional Improvement

POLICY NUMBER

A.2.01.107

DESCRIPTION

Hypertrophic scars and keloids are cutaneous lesions resulting from abnormal wound healing. There is no gold standard therapy for hypertrophic scars and keloids, and treatment frequently involves multiple techniques including pharmacotherapy, compression, surgery, radiation, and light sources. For scars and keloids impairing function, fractional carbon dioxide (CO2) ablative laser treatment is proposed to improve abnormal texture, thickness, and stiffness of scars by ablative destruction and resurfacing. The treatment may be used as monotherapy or in combination with other therapies (e.g., sequential treatment with other lasers, sequential treatment with other therapies, or laser-assisted drug delivery).

Hypertrophic Scars and Keloids

Hypertrophic scars and keloids are cutaneous lesions resulting from abnormal wound healing. Hypertrophic scars present as raised lesions that do not exceed the limits of the original skin injury. They tend to regress spontaneously within 1 year. Keloids present as raised, firm lesions that extend beyond the margins of original injury. Keloids do not regress spontaneously, are often refractory to treatment, and have a high probability of recurrence after excision. The highest prevalence of keloids is in people of color, with an incidence of up to 16% in Black Africans. Keloids can occur months or years after injury.

Consensus-based clinical recommendations published in 2014 endorsed the use of a scar classification system first developed in 2002. In this system, hypertrophic scars are classified as linear (e.g., surgical, traumatic) or widespread (e.g., burn). Keloids are classified as minor or major. Minor keloids are focally raised, itchy scars extending over normal tissue. Major keloids are large, raised (>0.5 cm) scars, possibly painful or pruritic, and extending over normal tissue. Major keloids are often refractory to treatment and have a high probability of recurrence after excision. Mature scars are light-colored and flat. Immature scars are slightly elevated in the process of remodeling and may be painful or itchy. Immature hypertrophic scars (red, slightly raised) may develop into hypertrophic scars; if they persist for longer than 1 month, the guidelines recommend treating them as a linear hypertrophic scar.

There is no gold standard therapy for hypertrophic scars and keloids, and treatment frequently involves multiple techniques including pharmacotherapy, compression, surgery, radiation, and light sources.

Laser Therapy for Scar Treatment

Carbon dioxide (CO2) fractional laser treatment was initially developed for cosmetic purposes (e.g., photoaging, acne scarring). Fractional CO2 laser ablation works by creating microscopic thermal wounds, resulting in tissue vaporization and coagulation of surrounding extracellular proteins The technique has the advantage of reaching the dermis by ablating the epidermis, while avoiding complications associated with nonfractional ablative lasers (no longer in use), such as postoperative pain and infection. For scars and keloids impairing function, CO2 fractional ablative laser treatment is proposed to improve abnormal texture, thickness, and stiffness of scars by ablative destruction and resurfacing. The treatment may be used as monotherapy or in combination with other therapies (e.g., sequential treatment with other lasers, sequential treatment with other therapies, or laser-assisted drug delivery).

This policy focuses on CO2 fractional ablative laser treatment for functional improvement. Other types of lasers used for hypertrophic scars and keloids include pulsed dye laser and intense pulse light.

Multiple fractional CO2 laser systems have been approved by the FDA through the 510(k) program. These devices have broad indications for dermatological procedures requiring ablation, resurfacing, and coagulation of soft tissue.

FDA Product Codes GEX, ONG.

Related medical policies –

• Negative Pressure Wound Therapy

• Electrostimulation and Electromagnetic Therapy for Treating Wounds

• Non-Contact Ultrasound Treatment for Wounds

POLICY

Carbon dioxide (CO2) fractional laser ablation treatment of hypertrophic scars or keloids for functional improvement is considered investigational.

POLICY EXCEPTIONS

Federal 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.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 HISTORY

05/01/2024: New policy added. Approved by the Medical Policy Advisory Committee.

03/05/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.107

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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