CurrentAetnaPolicy 0389

Hypertrophic Scars and Keloids

Defines Aetna's medical necessity and experimental/investigational determinations for interventions to treat hypertrophic scars and keloids, and lists associated CPT/HCPCS/ICD-10 codes; applies to Aetna members/providers.

Policy Summary

PayerAetna

PolicyHypertrophic Scars and Keloids

Policy CodePolicy 0389

Change TypeNo material change

Effective DateOct 4, 2000

Next Review DateApr 11, 2024

Key ActionDocument failure of conservative therapies and objective scar assessments before requesting coverage for fractional ablative laser.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Medically necessary categories

34+Experimental/investigational items

17110,0479TExample CPT codes

06/22/2023Last review

Coverage Criteria

Medical Necessity — Aetna considers the following interventions medically necessary:

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Experimental and Investigational — Interventions considered experimental/investigational for hypertrophic scars or keloids

Experimental and Investigational — Aetna considers the following interventions experimental and investigational for hypertrophic scars or keloids because the effectiveness has not been established:

Adipose‑derived stem cell

Adipose‑derived stromal vascular fraction

Anti‑vascular endothelial growth factor therapy (e.g., bevacizumab)

Autologous fat grafting

Basic fibroblast growth factor

Calcium antagonists

Combined micro‑plasma radiofrequency with hypo‑fractionated electron‑beam radiation

Dermal substitutes

Etanercept

Extracorporeal shock wave therapy

Growth hormone‑releasing peptide 6

Hyaluronidase

Hyperbaric oxygen therapy

Imiquimod cream

Intense pulsed light

Interferon alpha

Interleukin‑10

Intermittent magnetic pressure therapy

Intralesional bleomycin

Intralesional botulinum toxin type A injection

Intralesional fiber laser device (for keloids)

Intralesional mitomycin

Laser‑assisted drug delivery (e.g., administration of corticosteroid)

Losartan ointment

Mesenchymal stem cells

Micro‑needling (with Dermapen disposable tips or other devices/tools)

Non‑ablative fractional laser

Photodynamic therapy

Radiofrequency treatment (including plasma radiofrequency ablation)

Silicone products (e.g., gel, rigid shells, sheeting)

Topical calcipotriol

Topical oxandrolone

Topical retinoids

Transforming growth factor beta1

Evidence summaries by therapy — Evidence summaries and comparative outcomes from systematic reviews, meta‑analyses, RCTs, animal and in‑vitro studies

Evidence summaries by therapy — Evidence summaries and comparative outcomes from systematic reviews, meta‑analyses, RCTs, animal and in‑vitro studies:

Fractional ablative laser (AFL): Multiple prospective cohort studies, randomized trials, systematic reviews and large observational series report improvements in objective scar scales (e.g., VSS, POSAS, Manchester Scar Scale), symptom scores (pain, pruritus), scar thickness, and patient‑reported quality of life for burn, traumatic and post‑surgical scars. Studies vary in design, timing of treatment (early vs delayed), laser type (CO2, Er:YAG), and outcomes; heterogeneity limits pooled estimates. International consensus and guideline sources note AFL shows promise but that higher‑quality RCTs and standardized protocols are needed.

Early/Prophylactic Laser: RCTs and reviews of early laser (within 3 months of injury or within 6 months after surgery) show mixed results; some split‑scar RCTs favor laser on certain scales while overall heterogeneity and inconsistent reporting render conclusions uncertain.

Non‑ablative fractional laser (NAFL): Comparative split‑scar randomized trial found no statistically significant difference in observer scores between NAFL and AFL; patient satisfaction was high with both modalities but AFL associated with greater pain.

Botulinum toxin (BTX): Systematic reviews and meta‑analyses of small, heterogeneous RCTs report some improvements in scar width, VAS, and patient satisfaction for facial/neck scars, but methodological limitations, variability in dosing/technique, and small sample sizes preclude definitive conclusions. Further large, standardized RCTs are required.

Calcium antagonists (e.g., verapamil): Meta‑analyses and trials report mixed results; some trials suggest comparable effects to corticosteroids but higher risk of bias and an RCT demonstrated higher recurrence with verapamil versus triamcinolone after excision, leading to conclusion that verapamil is safe but not clearly superior.

Imiquimod 5% cream: Case series and small RCTs show highly variable recurrence rates after excision; a meta‑analysis showed very low certainty and inconsistent results (overall high variability by location), and imiquimod is not recommended as a reliable therapy.

Laser‑assisted drug delivery: Systematic review of RCTs found heterogeneity across small trials; evidence insufficient to recommend routine use and larger, high‑quality RCTs are needed.

Autologous fat grafting and adipose‑derived stromal vascular fraction: Case series and low‑quality studies report potential improvements in scar quality and symptoms, but evidence is limited to small, uncontrolled studies and controlled trials are lacking.

Anti‑VEGF (bevacizumab): Preclinical (animal) data suggest reduction in hypertrophic scarring; no published clinical data on local/topical bevacizumab for scars.

Interleukin‑10, photodynamic therapy, plasma radiofrequency ablation, extracorporeal shock wave therapy, hyperbaric oxygen therapy, mesenchymal stem cells, magnetic pressure therapy and other listed investigational modalities: Evidence is preliminary (in‑vitro, animal studies, small case series or pilot trials) and insufficient to establish safety and effectiveness in humans; further well‑designed clinical trials are required.

Pressure therapy and intralesional corticosteroids: Systematic reviews support pressure therapy for burn hypertrophic scars and intralesional triamcinolone as standard non‑surgical management with evidence for improvements in scar parameters; combination approaches (surgery + adjuvant therapy) are commonly used for keloids with variable recurrence rates depending on modality and location.

Background evidence (no coverage criteria in this excerpt)

Background evidence (no coverage criteria in this excerpt) — key study findings and context:

ThermaCool radiofrequency: Small uncontrolled study found collagen morphology changes but no clinical improvement in hypertrophic scars or keloids; ThermaCool alone did not achieve clinical benefit.

Interferon alpha‑2b: Prospective study found higher recurrence when used post‑excision compared with triamcinolone; concluded not effective.

Pressure therapy: Meta‑analysis of RCTs in burn patients showed improvements in VSS and scar characteristics for 15–25 mmHg; study limitations noted.

Extracorporeal shock wave therapy, plasma radiofrequency ablation, and other novel device‑based approaches: Animal and small human studies exist with mixed outcomes; keloid patients were often excluded from small P‑RF studies due to poor results.

Hyperbaric oxygen therapy: Small meta‑analysis suggests reduced recurrence after surgery/radiotherapy and improved VSS and satisfaction, but limited number and quality of trials necessitate further research.

MAIT cell percentage and other biomarkers: Emerging translational research suggests potential diagnostic biomarkers (e.g., reduced MAIT cells in keloid patients) but clinical utility is not established.

Clinical practice guidance and reviews: International guidelines and UpToDate summarize that laser therapy (especially fractional ablative) may be useful in selected scars, particularly when conservative measures fail, but they classify some laser approaches as investigational or with limited supporting evidence and call for additional RCTs and standardized outcome reporting.

Coding

CPT Codes Not Covered / RelatedCPTNot Covered

15769	Grafting of autologous soft tissue, other, harvested by direct excision (e.g., fat, dermis, fascia)
15771	Grafting of autologous fat harvested by liposuction technique to trunk, breasts, scalp, arms, and/or legs; 50 cc or less injectate
99183	Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session
11042-11047	Debridement; subcutaneous tissue, muscle/fascia, bone (related CPT debridement codes)

HCPCS/Drug Codes (mixed — covered or not covered as specified)HCPCS

J0702	Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg
J3300	Injection, triamcinolone acetonide, preservative free, 1 mg
J9190	Fluorouracil, 500 mg
J9040	Injection, bleomycin sulfate, 15 units
J0585	Injection, onabotulinumtoxinA, 1 unit [Botox] (listed as not covered for indications in CPB)
A6025	Gel sheet for dermal or epidermal application (e.g., silicone), each (listed as not covered)

ICD-10 Diagnosis Codes (covered if selection criteria met)ICD-10Covered

L90.5	Scar conditions and fibrosis of skin
L91.0	Hypertrophic scar [keloid]

Covered CPT Codes (if selection criteria met)CPTCovered

17110	Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; up to 14 lesions [covered for keloid scar documented to be painful, ulcerated, pruritic causing a functional impairment (i.e. restricted movement)]
17111	Destruction of benign lesions; 15 or more lesions [keloid scars]
11900	Injection, intralesional; up to and including 7 lesions [corticosteroids]
11901	Injection, intralesional; more than 7 lesions [corticosteroids]
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; 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)

Provider Actions and Authorization

Prior Authorization

Prior Authorization for Fractional Ablative Laser

Prior authorization may be required for fractional ablative laser (CPT 0479T, 0480T) when used for burn, traumatic, or post‑surgical scars. Authorization is generally considered only when documentation shows significant functional impairment (for example, restricted movement) and prior trial and failure of conventional conservative therapies (e.g., hypoallergenic paper tape, silicone gel/sheeting, pressure garments) have been attempted and documented.

Affected codes: 0479T, 0480T
Document trial and failure of conservative therapies (see documentation callout)

Prior Authorization

BTX‑A Prior Authorization Consideration

Botulinum toxin A (BTX‑A) injections have RCTs and meta‑analyses reporting improvements in scar width, VSS/VAS scores, and patient satisfaction; prior authorization may be considered on a case‑by‑case basis depending on plan benefits and submitted evidence.

Evidence: multiple RCTs and meta‑analyses (e.g., Zhang 2016; Qiao 2021)
Consider documenting scar location, prior treatments, and objective measures

Prior Authorization

Prior Authorization for AFL Procedures

Given evolving practice patterns and evidence that CO2‑AFL has been associated with reduced length of stay and anesthetic time in some series, prior authorization for ablative fractional laser (AFL) procedures may require additional clinical documentation supporting medical necessity and that conservative measures were tried.

Document expected clinical benefit and prior conservative therapy
Consider operative/anesthesia implications when determining authorization

Prior Authorization

Authorization Likely for Radiotherapy and HBOT

Authorization is likely for excision with adjuvant radiotherapy and for hyperbaric oxygen therapy (HBOT) when supported by clinical documentation consistent with the Clinical Policy Bulletin and plan benefits.

Radiotherapy for chest keloids: recurrence data support use as adjuvant therapy
HBOT: meta‑analysis suggests reduced recurrence after surgery/radiotherapy

Prior Authorization

Prior Authorization per Clinical Policy Bulletin

Coverage and prior authorization requirements are governed by this Clinical Policy Bulletin and the member's individual plan benefits. Providers should follow Aetna procedures for submitting prior authorization requests and supporting documentation.

Follow Clinical Policy Bulletin procedures and individual plan benefits
Prior authorization determinations depend on submitted documentation and plan terms

Note

Prior Authorization Not Specified in This Section

This section does not specify universal prior authorization triggers for all listed interventions. Some therapies may be subject to prior authorization depending on plan benefits, coding, and whether interventions are considered experimental/ investigational for the indication.

Not all interventions in this section have explicit prior authorization rules
Check member's plan documents for applicability

Note

Background Evidentiary Implications

The evidence base includes heterogeneous study designs, variable quality, and evolving literature; experimental or insufficient evidence for some therapies increases the risk of denial if clinical justification or high‑quality supporting data are not provided.

Heterogeneity and low quality of some trials may affect authorization decisions
Experimental/insufficient evidence treatments (see policy list) are at higher denial risk

Note

Verapamil vs Triamcinolone Recurrence Risk

A randomized split‑scar RCT showed higher keloid recurrence with verapamil compared with intralesional triamcinolone (hazard ratio 8.44); verapamil was safe but less effective, and the trial was terminated early for inferiority. This impacts expectations for verapamil as an alternative to corticosteroids.

Study: Danielsen et al (2016) — verapamil vs triamcinolone; higher recurrence with verapamil
Implication: document rationale if verapamil is used instead of triamcinolone

Denial Risk

P‑RF for Keloids Excluded in Reported Series

Patients with keloids were excluded from reported plasma radiofrequency (P‑RF) ablation series due to unsatisfactory results; P‑RF for keloids lacks supportive evidence and may be considered unsuitable or experimental for keloid treatment.

P‑RF studies excluded keloid patients due to poor outcomes
Treating providers should document rationale if using P‑RF in atypical cases

Denial Risk

Experimental / Insufficient Evidence Risk

Therapies listed as experimental or investigational in this policy (e.g., adipose‑derived stem cell therapy, intralesional botulinum toxin for keloids, dermal substitutes, extracorporeal shock wave therapy) carry an increased risk of denial due to insufficient evidence; provide robust clinical justification and supporting literature if requesting coverage.

Refer to policy's Experimental and Investigational list for non‑covered interventions
Submit peer‑reviewed evidence if requesting exception

Note

No Explicit Authorization or Denial Triggers

There are no explicit automatic authorization or denial triggers listed in these supplemental provider‑actions; decisions are determined by plan benefits, evidence quality, and the adequacy of submitted clinical documentation.

Authorization decisions are individualized
Lack of explicit triggers means documentation quality drives decisions

Documentation Required

Background

Background and pathophysiologic context note that keloids and hypertrophic scars result from dermal tissue proliferation after skin injury and that laser therapies, pressure therapy, intralesional agents, and surgical approaches have varying levels of evidence; the policy’s evidence summaries and cited studies provide clinical context but do not replace individual plan coverage rules.

Keloids and hypertrophic scars are described as abnormal dermal proliferations arising after skin injury; epidemiologic estimates in background sections indicate these lesions occur in a minority of wounds, and common first‑line or adjunctive therapies include silicone gel sheeting and intralesional corticosteroids, while many novel or device‑based interventions remain investigational.

Definitions

Silicone gel sheeting — definition and typical use

DefinitionSoft, slightly adherent, semi-occlusive covering fabricated from medical-grade silicone polymers used to reduce scar volume and improve elasticity of hypertrophic and keloid scars; available as sheets, gels, or rigid shells (OTC brands: Sil-K, Cica-Care, ReJuveness, DuraSil, Silastic; Epi-Derm prescription).

Typical useApplied to scars (donor/recipient sites, burns) as a dressing or adjunctive therapy to improve appearance and symptoms (pruritus, burning pain) and to increase scar elasticity.

Evidence summaryCase series report improvements in scar size, erythema, elasticity and symptoms, but prospective randomized controlled trials are limited and results are inconsistent compared with standard wound dressings.

Formulations/examplesGel sheeting, topical silicone gel, custom-molded rigid shells; examples include Sil-K, Cica-Care, ReJuveness, DuraSil, Silastic, and Epi-Derm.

Intralesional therapy — definition (agents like corticosteroids, 5-FU)

DefinitionInjection of therapeutic agents directly into keloid or hypertrophic scar tissue to reduce scar size and symptoms.

Common agentsCorticosteroids (e.g., triamcinolone acetonide) and antimetabolites (e.g., 5-fluorouracil) — used alone or in combination with other modalities (e.g., pulsed-dye laser).

Purpose/mechanismAims to soften and flatten scars by inhibiting fibroblast proliferation and collagen synthesis; corticosteroids also reduce inflammation and pruritus.

EvidenceMultiple clinical trials demonstrate effectiveness of intralesional 5-FU and combinations (TA + 5-FU ± PDL) with higher improvement rates than steroid alone in some studies.

intralesional therapy (synonym entry)

TermIntralesional therapy (synonym entry)

Short definitionDirect injection of agents into scar tissue (e.g., corticosteroids, 5-FU) to reduce scar volume and symptoms.

ContextUsed as standard non-surgical management and often combined with other modalities in clinical practice and trials.

NAFL — Non-ablative fractional laser definition

DefinitionNon-ablative fractional laser (NAFL) — a noninvasive laser approach that creates columns of thermal injury to remodel dermal tissue without full-thickness epidermal ablation.

Mechanism/goalStimulates dermal remodeling and collagen reorganization while preserving epidermal continuity, often with lower downtime and pain than ablative lasers.

Examples/ wavelengthsExamples include erbium:glass (1,550 nm) and thulium (1,927 nm) NAFL systems, often combined with PDL for vascular components.

EvidenceRCTs and split‑scar trials show mixed objective improvements; some patient-reported benefits despite limited blinded observer confirmation.

Pathogenesis theories — proposed mechanisms for keloid formation

Proposed mechanismsIschemia theory — abnormal blood flow/angiogenesis contributing to scar overgrowth.

Inflammatory/immune interactionsImmune theory and TGF-β interactions — dysregulated growth factor signaling (e.g., TGF-β) and immune responses promote collagen overproduction.

Cellular contributorsMast cell theory — mast cell activation driving fibrosis; alterations in collagen turnover and fibroblast activity.

Mechanical/genetic factorsMechanical theory — tension alignment and mechanical forces influence scar shape and growth; genetic predisposition also implicated.

Anti-VEGF therapy (e.g., bevacizumab) — experimental approach

ApproachAnti-VEGF therapy (e.g., bevacizumab) aims to inhibit angiogenesis implicated in hypertrophic scar formation by reducing VEGF activity.

Preclinical evidenceIn rabbit ear models, bevacizumab reduced scar elevation index, VEGF levels, and vessel counts compared with saline (statistically significant differences reported).

Clinical statusNo published studies on local injection or topical application to human scars; clinical safety and effectiveness remain unestablished.

Vancouver Scar Scale (VSS) — clinician-rated scar scale

DefinitionVancouver Scar Scale (VSS) — an objective clinician‑rated scale assessing pigmentation, vascularity (erythema), pliability, and height (thickness) to quantify scar severity and response.

Use in studiesUsed widely in laser and scar intervention studies as a primary objective outcome measure for pigmentation, erythema, pliability, and height changes.

InterpretationLower VSS scores indicate improvement; changes used to document treatment effect in cohort and randomized studies.

Ablative fractional laser (AFL) — definition and examples (CO2, Er:YAG)

DefinitionAblative fractional laser (AFL) — a laser modality that creates microthermal zones of full‑thickness ablation in the epidermis and dermis to stimulate dermal remodeling and improve scar thickness, texture, and pigmentation.

ExamplesCommon AFL systems include fractional CO2 and Er:YAG (Er:YAG may show favorable molecular remodeling in preclinical models).

Clinical useUsed for hypertrophic burn and post‑surgical scars to improve objective measures (VSS, thickness) and symptoms (pain, pruritus); may require multiple sessions.

Non-ablative fractional laser (NAFL) — definition and examples

DefinitionNon‑ablative fractional laser (NAFL) — a fractional laser that produces dermal thermal remodeling without full‑thickness epidermal ablation to target scar texture and pigmentation with lower downtime.

ExamplesExamples in studies include 1,550 nm erbium:glass and 1,927 nm thulium NAFL systems, sometimes combined with PDL for vascularity control.

Clinical findingsSplit‑scar RCTs report mixed objective findings; patients may report improved appearance though blinded physician assessments are sometimes non‑significant.

Indications for laser therapy — typical indications

Typical indicationsImmature or linear hypertrophic erythematous scars persisting >1 month despite preventive treatment (silicone gel/sheeting, hypoallergenic tape, onion extract).

Widespread burn scarsWidespread hypertrophic burn scars that have failed conservative therapy (silicone gel/sheeting, pressure garments, onion extract) for 8–12 weeks are candidates for laser therapy.

Symptomatic or functional scarsScars causing persistent erythema, pain, pruritus, or functional limitation (e.g., contracture limiting movement) may be considered for laser modalities when conservative measures fail.

Documentation requirementObjective scar assessments (e.g., VSS, POSAS), photographic documentation, and documentation of failed conservative therapy are recommended to support candidacy.

Intralesional triamcinolone acetonide (TAC) — dosing and mechanism

Agent and dosingIntralesional triamcinolone acetonide (TAC) — commonly used at concentrations of 10 to 40 mg/mL administered intralesionally.

MechanismCorticosteroids soften and flatten scars by diminishing collagen and glycosaminoglycan synthesis and inhibiting fibroblast proliferation; anti‑inflammatory and vasoconstrictive effects reduce pain and pruritus.

Treatment intervalTreatments are usually repeated every 4 to 6 weeks; optimal concentration and number of treatments are not definitively established.

Role in stepwise careDescribed as the standard non‑surgical therapy and often expected to be tried before advanced or experimental modalities.

Hyperbaric oxygen therapy (HBOT) — definition and reported effects

DefinitionHyperbaric oxygen therapy (HBOT) — breathing pure or high‑concentration oxygen at pressures above atmospheric in an enclosed chamber to enhance tissue oxygenation.

Reported effectsMeta-analysis of selected studies (4 included: 1 RCT, 1 CCT, 2 cohorts) reported reduced recurrence after surgery/radiotherapy (OR 0.26), increased patient satisfaction (OR 4.45), and improved VSS scores (SMD -3.82).

Evidence caveatAvailable studies are limited (small number selected from many publications); authors call for more RCTs and longer‑term data to confirm findings and safety.

OpenPayer

Hypertrophic Scars and Keloids

Coverage Criteria

Coding

Provider Actions and Authorization

Background

Definitions

Revision History