Clinical UM Guideline

 

Subject: Treatment of Keloids and Scar Revision
Guideline #:  CG-SURG-31 Publish Date:    04/25/2018
Status: Revised Last Review Date:    03/22/2018

Description

This document describes the medically necessary and reconstructive indications for the treatment of keloids and scar revision.

Note: Please see the following related documents for additional information:

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant physical functional impairment AND the procedure can be reasonably expected to improve the physical functional impairment. 

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or a congenital defect.

Note: Not all benefit contracts/certificates include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance. 

Clinical Indications

I.  Treatment of Keloids

Medically Necessary:

Treatment of a keloid is considered medically necessary when there is documented evidence of significant physical functional impairment related to the keloid and the treatment can be reasonably expected to improve the physical functional impairment.

Treatment of a keloid with radiation therapy (up to 3 fractions) is considered medically necessary as adjunct therapy following surgical excision (initiated within 3 days) when the medically necessary criteria for keloid removal are met.

Reconstructive:

Treatment of a keloid is reconstructive when the keloid results in a significant variation from normal related to accidental injury, disease, trauma, or treatment of a disease.

Treatment of a keloid with radiation therapy (up to 3 fractions) is considered medically necessary as adjunct therapy following surgical excision (initiated within 3 days) when the reconstructive criteria for keloid removal are met.

Cosmetic and Not Medically Necessary:

Treatment of keloids is considered cosmetic and not medically necessary when performed in the absence of a significant physical functional impairment, is not reconstructive, and is intended to change a physical appearance that would be considered within normal human anatomic variation.

II.  Scar Revision

Medically Necessary:

Scar revision is considered medically necessary when there is documented evidence of significant physical functional impairment related to the scar and the treatment can be reasonably expected to improve the physical functional impairment.

Fractional ablative carbon dioxide laser fenestration of a burn scar or traumatic scar is considered medically necessary when there is documented evidence of significant physical functional impairment related to the scar (that is, limited movement) and the treatment can be reasonably expected to improve the physical functional impairment and the individual has tried at least one other scar revision intervention (for example, silicone gel or sheeting, or pressure garments).

Reconstructive:

Scar revision is considered reconstructive when there is significant variation from normal related to accidental injury, disease, trauma, or treatment of a disease or congenital defect.

Cosmetic and Not Medically Necessary:

Scar revision is considered cosmetic and not medically necessary when performed in the absence of a significant physical functional impairment, is not reconstructive, and is intended to change a physical appearance that would be considered within normal human anatomic variation.

Fractional ablative carbon dioxide laser fenestration is considered cosmetic and not medically necessary when performed in the absence of a significant physical functional impairment and is intended to change a physical appearance that would be considered within normal human anatomic variation. Examples include, but are not limited to, enhance the appearance of the upper layer of the skin as a result of acne, acne scars, uneven pigmentation or wrinkles.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

11400-11446

Excision benign lesions [includes codes 11400, 11401, 11402, 11403, 11404, 11406, 11420, 11421, 11422, 11423, 11424, 11426, 11440, 11441, 11442, 11443, 11444, 11446]

12031-13153

Repair, intermediate complex [includes codes 12031, 12032, 12034, 12035, 12036, 12037, 12041, 12042, 12044, 12045, 12046, 12047, 12051, 12052, 12053, 12054, 12055, 12056, 12057, 13100, 13101, 13102, 13120, 13121, 13122, 13131, 13132, 13133, 13151, 13152, 13153]

14000-14302

Adjacent tissue transfer or rearrangement [includes codes 14000, 14001, 14020, 14021, 14040, 14041, 14060, 14061, 14301, 14302]

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

 

 

ICD-10 Procedure

 

0HN0XZZ-0HNNXZZ

Release, skin, external approach [by body area; includes codes 0HN0XZZ, 0HN1XZZ, 0HN2XZZ, 0HN3XZZ, 0HN4XZZ, 0HN5XZZ, 0HN6XZZ, 0HN7XZZ, 0HN8XZZ, 0HN9XZZ, 0HNAXZZ, 0HNBXZZ, 0HNCXZZ, 0HNDXZZ, 0HNEXZZ, 0HNFXZZ, 0HNGXZZ, 0HNHXZZ, 0HNJXZZ, 0HNKXZZ, 0HNLXZZ, 0HNMXZZ, 0HNNXZZ]

 

 

ICD-10 Diagnosis

 

L73.0

Acne keloid

L90.5

Scar conditions and fibrosis of skin

L91.0

Hypertrophic scar (keloid)

Also the following for adjunct keloid treatment:

CPT

 

77261

Therapeutic radiology treatment planning; simple

77290

Therapeutic radiology treatment planning; intermediate

77300

Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician

77332

Treatment devices, design and construction; simple (simple block, simple bolus)

77334

Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts)

77401

Radiation treatment delivery, superficial and/or ortho voltage, per day

77402

Radiation treatment delivery; > 1 MeV; simple

77407

Radiation treatment delivery; > 1 MeV; intermediate

77412

Radiation treatment delivery; > 1 MeV; complex

77431

Radiation therapy management with complete course of therapy consisting of 1 or 2 fractions only

 

 

ICD-10 Diagnosis

 

L73.0

Acne keloid

L91.0

Hypertrophic scar (keloid)

Discussion/General Information

Concepts of Medical Necessity, Reconstructive, and Cosmetic

The coverage eligibility of medical and surgical therapies to treat skin conditions is often based on a determination of whether treatment is considered medically necessary, reconstructive, or cosmetic in nature.

Description of the Condition

Keloids

Keloids are an overgrowth of scar tissue in response to skin injury causing a raised, hardened section of skin. Similar to hypertrophic scars, keloids are bulkier and extend beyond the borders of the original site of injury. Keloids occur as a result of acne, burns, chicken pox, skin injuries such as surgical incisions, traumatic wounds, vaccination sites, ear piercings, or even minor scratches. Keloids can occur on any part of the body, but typically occur on the ear lobes, shoulders, chest, and back. Some keloids cause symptoms of pain and pruritus, redness, unusual sensations at the site, and may result in hyperpigmentation and disfigurement (Lee, 2015). Keloids occur in both genders, although a predominance has been reported in females, and can occur in all skin types. In some individuals, keloids can cause a high degree of symptoms which affects their ability to perform normal activities (for example, interferes with sleep). Suboptimal tissue healing can result in impaired function. The recurrence rate of keloids after excision alone has been reported at 45% to 100%. Additionally, the peer-reviewed medical literature notes that keloids may become larger in size after treatment.

Scars

Scar formation may result from healed wounds, lesions from diseases, surgical operations, or trauma. The amount of scarring may be determined by the size, depth, and location of the wound, the age of the person, heredity, and skin characteristics including color (pigmentation). Scar tissue may be associated with symptoms of discomfort, become hypertrophic, or breakdown. Hypertrophic scarring typically occurs within 4 to 8 weeks following wound infection, wound closure with excess tension or other traumatic skin injury, and has a rapid growth phase for up to 6 months. Hypertrophic scarring may gradually regress over a period of a few years, eventually leading to flat scars with no further symptoms (Gauglitz, 2011). A contracture is a severe form of a scar and is commonly associated with thermal injuries. Surgical scar revision is a procedure intended to remove scar tissue by cutting it out (excising) and closing the area in a new configuration that restores function and corrects skin changes or disfigurement. The revisions may involve redirecting the tension lines with techniques such as W-plasty or Z-plasty. Some scar revision may involve more complex reconstruction using skin flaps and grafts.

Hypertrophic burn or traumatic scars are cutaneous lesions resulting from an excessive tissue response to dermal injury characterized by local fibroblast proliferation and overproduction of abnormal collagen. Gangemi and colleagues (2008) report that up to 77% of burn injuries develop pathological scarring, and of these, 44% result in hypertrophic scarring and 28% in both hypertrophic scarring and contractures; contractures alone are present in 5% of individuals with burns. Associated symptoms include pain, pruritus, restricted movement, decreased overall function, and disfigurement.

Prophylactic and therapeutic treatments that may be effective and performed as monotherapy or in combination with other therapeutic regimens for keloids or hypertrophic scar tissue that cause significant pain or result in a significant physical functional impairment include, but are not limited to, intralesional corticosteroid injections (with or without 5-fluorouracil) (Asilian, 2006; Manuskiatti, 2002; Nanda, 2004), ablative and non-ablative laser therapy and laser resurfacing with carbon dioxide (CO2), potassium-titanyl-phosphate (KTP), pulsed-dye, or YAG lasers (Alster, 2003; Alster, 2007; Asilian, 2006; Azzam, 2016; Bouzari, 2007; de las Alas, 2012; El-Zawahry, 2015; Hultman, 2013; Kwon, 2000; Mamalis, 2014; Manuskiatti, 2002; Tanzi, 2002), radiation therapy, and surgical excision or revision procedures (for example, W-plasty, Z-plasty, or small-wave incisions, with or without skin flap/grafting) (Atiyeh, 2007; Bermueller, 2010; Gauglitz; 2011; Mofikoya, 2007; Watson, 2012).

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 physical 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 (2017) 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. 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. Two similarly scarred skin areas of approximately 10 cm by 10 cm were defined with one 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=0.0144] and 5.2 to 2.60 [p=0.0032], 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=0.0129), and thickness (3.9 to 2.2; p=0.0192). 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 (2017) 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). 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-patient 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 (2016) 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. 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 four 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 posttreatment 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 posttreatment). Improvement in three of four 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 posttreatment.

Hultman and colleagues (2013) performed a prospective “before-after” study at a single center evaluating 147 individuals with hypertrophic burn scars involving a mean body surface area of 16%. 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)/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 immediately before the first session and 4 to 6 weeks later (at the time of the next session) with the VSS and a subjective, patient-reported University of North Carolina (UNC) designed “4P’’(UNC4P) Scar Scale which assessed four 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 (2014) reported on long-term follow-up (mean, 30.7 months) of the original study participants from 2011. 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 (Anderson, 2014) concluded:

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 (Gold, 2014) include the following recommendations:

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, postinflammatory 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 (2013) performed a meta-analysis of 28 well-designed clinical trials with 919 subjects evaluating the efficacy and safety of laser therapy in hypertrophic scar management. 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; however, the authors stated the level of evidence for laser therapy as a keloid treatment is low.

Radiation Therapy

Low- or high-dose radiation therapy (superficial [external beam] or interstitial [brachytherapy]) following excisional surgery has been reported to have higher response rates and lower recurrence rates for treatment-resistant keloids. Low-dose rate (LDR) and high-dose rate (HDR) brachytherapy for the treatment of keloids involves the placement of radioactive seeds or strands placed into a plastic tube that is sutured into the wound site after the keloid is surgically removed. In HDR, the total dosage is divided into lower-dosed sessions and administered over hours (that is, left in for seconds to minutes at a time) instead of over days. LDR implants are left in for 2 to 3 days and then removed. The tubes are removed after therapy and the wound is closed. External beam radiation therapy (EBRT) for treatment of keloids is administered after surgical excision by low-voltage photon X-ray or high-energy (voltage) electrons delivered by linear accelerator in divided doses, once or twice daily for up to a total treatment dose.

Gupta and Sharma (2011) reported on standard guidelines of care for keloids in a review article evaluating the evidence in the peer-reviewed medical literature for the type of radiation used, timing of treatment, and dosage of radiation used in the treatment of keloids, stating:

Lee and Park (2015) retrospectively evaluated a case series of 37 keloids to determine the appropriate time for initiating external beam (electron) radiation therapy following surgical excision. Radiation therapy was initiated within 24 hours in 24 lesions, between 24 and 72 hours in 6 lesions, and after more than 72 hours in 7 lesions. The median follow-up period was 27.4 months. Seven lesions recurred, including five lesions reoccurring in high stretch-tension regions (p=0.010); initial treatments in these lesions were administered within 24 hours in one lesion and more than 72 hours after surgical excision in six lesions (p<0.0001). The investigators concluded that radiotherapy should be initiated to the keloid site within 72 hours of surgical excision.

As early as 1994, Klumpar and colleagues reported that radiation therapy following postsurgical excision of keloids resulted in high control rates of 72% to 92%. In a large, single-institution case-control retrospective study, Hoang and colleagues (2017) reported on the 10-year effects of surgical excision and adjuvant brachytherapy versus external beam radiation for the treatment of keloids, stating:

…surgically excised keloids reportedly recur at a rate of > 45%. Post-excision radiation (RT) has been delivered via external beam radiotherapy (EBRT) or interstitial high dose rate (HDR) brachytherapy. Despite historical data showing 10% to 20% keloid recurrences with post-excision RT, there is a paucity of high-quality evidence comparing keloid recurrences between the two RT modalities.

A total of 128 individuals with 264 keloid lesions were treated by excision alone (n=28), post-excision EBRT (n=197), or post-excision HDR brachytherapy (n=39). Participant and keloid recurrence data were analyzed using mixed effect Cox regression modeling (statistical threshold, p<0.05). A total of 54% of keloids recurred after surgical excision alone (9-month median follow up); 19% of keloids recurred with post-excision EBRT (42-month median follow up); 23% of keloids recurred with post-excision brachytherapy (12-month median follow up). Adjuvant EBRT and brachytherapy each showed significant control of keloid recurrence compared to excision alone (p<0.01). EBRT significantly delayed the time of keloid recurrence over brachytherapy by a mean difference of 2.5 years (p<0.01).

In a review article, Kal and Veen (2005) state that a relatively high-dose radiation must be applied in a short overall treatment time for successful prevention of recurrence of keloids after surgical excision. The optimal treatment may be a radiation strategy resulting in a BED value of at least 30 Gy. A BED value of 30 Gy can be obtained with, for instance, 1 single acute dose of 13 Gy, 2 fractions of 8 Gy, or 3 fractions of 6 Gy, or 1 single dose of 27 Gy at low-dose rate. The authors recommend that radiation treatment should be administered within 2 days following surgery. In follow-up, Kal and colleagues (2009) performed a retrospective review of the literature, concluding that most doses of radiation therapy used for prevention of keloid recurrence after surgery are too low. They suggest a treatment strategy of BED value of at least 30 to 40 Gy should be applied using an alpha/beta ration of 10 to prevent recurrences of keloids.

Additional comparative studies (Emad, 2010; Sclafani, 1996), a prospective study (van Leeuven, 2014); retrospective case studies (Carvajal, 2016; De Cicco, 2014; Guix, 2001; Kim, 2015; Kuribayashi, 2011; Ogawa, 2003; Ogawa, 2007; Shen, 2015), a systematic review and meta-analysis (Shin, 2016), and other systematic reviews (Flickinger, 2011; van Leeuven, 2015) suggest that keloids are effectively treated with a combination of surgical excision and radiation therapy (including EBRT or brachytherapy) in the immediate postoperative period.

Adverse reactions of radiation therapy at the surgically removed keloid site may include skin redness, skin peeling, telangiectasia and permanent skin color changes (generally hypopigmentation) (Gupta and Sharma, 2011). In a systematic review and examination of evidence-based opinions of radiation oncologists regarding the acceptability of using radiation to treat keloids, Ogawa and colleagues (2009) concluded the “risk of carcinogenesis attributable to keloid radiation therapy is very low when surrounding tissues, including the thyroid and mammary glands, especially in children and infants, are adequately protected, and that radiation therapy is acceptable as a keloid treatment modality.” In a retrospective analysis of control and toxicity rates in 116 individuals with keloids who underwent postoperative brachytherapy and electron beam radiation, Duan and colleagues (2015) reported no definitive evidence was found for an association between radiotherapy and the occurrence of cancer during the follow-up period (median observation period: 46.5 months (range, 10.0-120.0 months) for all participants).

Definitions

Brachytherapy: A type of radiation treatment given by placing radioactive material directly into the target area; also known as internal or interstitial radiation therapy.  

External beam radiation therapy (EBRT): A type of low-dose radiation treatment used in combination (adjunctive) with surgical excision for the treatment of keloids. EBRT uses highly focused beams of light called superficial X-rays to destroy collagen-producing cells and limit the growth of new cells.

Hypertrophic scar: An elevated scar that is typically raised, erythematous (red, pink, or purple) and stiffer than the surrounding skin. Hypertrophic scars are more commonly found in areas of high skin tension, or on people with darker skin tones.

Keloid: A condition where a scar becomes raised above the flat surface of normal skin, has a hardened texture, and may grow beyond the boundaries of the scar.

Patient and Observer Scar Assessment Scale (POSAS): A numeric rating scale used in the clinical evaluation of scar areas. The POSAS consists of two parts: the Patient Scar Assessment Scale and the Observer Scar Assessment Scale, completed by the patient and the observer, respectively. The Observer Scale consists of six items: vascularity, pigmentation, thickness, relief, pliability and surface area. All items are scored on a scale ranging from 1 (‘like normal skin’) to 10 (‘worst scar imaginable’). The sum of the six items results in a total score of the POSAS observer scale (Draaijers, 2004).

Scar: A mark left in the skin by the healing of a wound, sore, or injury because of the replacement by connective tissue of the injured issues.

Significant physical functional impairment: Limits on normal physical functioning that may include, but are not limited to, problems with communication, respiration, eating, swallowing, visual impairments, skin integrity, distortion of nearby body parts, or obstruction of an orifice. The cause of the physical functional impairment may be pain, structural integrity, congenital anomalies or other factors. Significant physical functional impairment excludes social, emotional, and psychological impairments or potential impairments.

Vancouver Scar Scale (VSS): A widely used rating scale to assess hypertrophic burn scars by evaluating their rate of development and measuring outcomes of therapy or resolution. The VSS assesses four scar characteristics, with normal skin scoring 0 and an increasing score (total score of 13) assigned to a greater pathologic condition (Sullivan, 1990):

  1. Vascularity: 0-3 (Normal, Pink, Red, Purple);
  2. Height/thickness: 0-3 (Flat, <2 mm, 2-5 mm, >5 mm);
  3. Pliability: 0-5 (Normal, Supple, Yielding, Firm, Ropes, Contracture);
  4. Pigmentation: 0-2 (Normal, Hypopigmentation, Hyperpigmentation).
References

Peer Reviewed Publications:

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  2. Alster T, Zaulyanov L. Laser scar revision: a review. Dermatol Surg. 2007; 33(2):131-140.
  3. Anderson RR, Donelan MB, Hivnor C, et al. Laser treatment of traumatic scars with an emphasis on ablative fractional laser resurfacing: consensus report. JAMA Dermatol. 2014; 150(2):187-193.
  4. Asilian A, Darougheh A, Shariati F. New combination of triamcinolone, 5-fluorouracil, and pulsed-dye laser for treatment of keloid and hypertrophic scars. Dermatol Surg. 2006; 32(7):907-915.
  5. Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007; 31(5):468-492; discussion 493-494.
  6. Azzam OA, Bassiouny DA, El-Hawary MS, et al. Treatment of hypertrophic scars and keloids by fractional carbon dioxide laser: a clinical, histological, and immunohistochemical study. Lasers Med Sci. 2016; 31(1):9-18.
  7. Bermueller C, Rettinger G, Keck T. Auricular keloids: treatment and results. Eur Arch Otorhinolaryngol. 2010; 267(4):575-580.
  8. Bouzari N, Davis SC, Nouri K. Laser treatment of keloids and hypertrophic scars. Int J Dermatol. 2007; 46(1):80-98.
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  18. Guix B, Henriquez I, Andres A, et al. Treatment of keloids by high-dose-rate brachytherapy: a seven-year study. Int J Radiat Oncol Biol Phys. 2001; 50(1):167-172.
  19. Gupta S, Sharma VK. Standard guidelines of care: keloids and hypertrophic scars. Indian J Dermatol Venereol Leprol. 2011; 77(1):94-100.
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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Bickers DR, Lim HW, Margolis D, et al.; American Academy of Dermatology Association; Society for Investigative Dermatology. The burden of skin diseases: 2004 joint project of the American Academy of Dermatology Association and the Society for Investigative Dermatology. J Am Acad Dermatol. 2006; 55(3):490-500.
  2. Gold MH, McGuire M, Mustoe TA, et al. Updated international clinical recommendations on scar management: part 2--algorithms for scar prevention and treatment. Dermatol Surg. 2014; 40(8):825-831.
Index

External Beam Radiation Therapy
Fractional Ablative CO2 Lasers
High-Dose Rate (HDR) Brachytherapy
Laser Fenestration
Low-Dose Rate (LDR) Brachytherapy

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

History

Status

Date

Action

Revised

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Added a MN statement for fractional ablative CO2 laser fenestration of a burn scar or traumatic scar when criteria are met. Added a Cosmetic and NMN statement for fractional ablative CO2 laser fenestration of a burn scar or traumatic scar when criteria are not met. Added Index section. Updated Description, Discussion, Definitions and References sections. Updated Coding section to add 0479T and 0480T.

Revised

11/02/2017

MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Added MN and Reconstructive statements for treatment of a keloid with radiation therapy (up to 3 fractions) as adjunct therapy following surgical excision (initiated within 3 days) when the medically necessary or reconstructive criteria for keloid removal are met. Minor clarification to the Cosmetic and NMN statement. Updated Discussion, Definitions, Coding, and References sections. Removed Websites for Additional Information section.

Reviewed

02/02/2017

MPTAC review. Updated Discussion/General Information, References, and Websites for Additional Information sections.

Reviewed

02/04/2016

MPTAC review. Updated Websites for Additional Information section. Removed ICD-9 codes from Coding section.

Reviewed

02/05/2015

MPTAC review. Updated Discussion, References, and Websites for Additional Information sections.

Reviewed

02/13/2014

MPTAC review. Updated Discussion, References, and Websites for Additional Information sections.

Reviewed

02/14/2013

MPTAC review. Updated Web Sites for Additional Information. Removed the Index.

New

02/16/2012

MPTAC review. Initial document development. Transferred and rephrased contents and coding that address the treatment of keloids and scar revision from ANC.00007 Cosmetic and Reconstructive Services: Skin Related.