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Phototherapy for Acne
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Defines Aetna's coverage stance on various phototherapy and photodynamic treatments for acne vulgaris and hidradenitis suppurativa, listing specific technologies/approaches considered experimental/investigational and related coding guidance for noncoverage.
No material clinical/coverage changes — the brief indicates has_material_change=false and there are no listed changes.
Coverage Summary
Defines Aetna's coverage stance on various phototherapy and photodynamic treatments for acne vulgaris and hidradenitis suppurativa as experimental and investigational (not covered for cosmetic/medical indications listed), listing specific technologies and approaches considered investigational.
Policy status: CURRENT. Last Review: 2023-09-14. Next Review: 2024-07-11. Effective (first use) date listed in review history: 04/25/2003.
Experimental / Investigational Criteria
Experimental and Investigational for Acne Vulgaris
Aetna considers the following treatments experimental and investigational for acne vulgaris because of insufficient evidence of effectiveness:
Experimental and Investigational for Acne Inversa (Hidradenitis Suppurativa)
Aetna considers the following treatments experimental and investigational for acne inversa (hidradenitis suppurativa) because of insufficient evidence:
Experimental and Investigational for Cystic Acne of the Scalp
Aetna considers the following experimental and investigational for cystic acne of the scalp:
Coding — Not Covered / Cosmetic
| 17110 | Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; up to 14 lesions. |
| 17111 | 15 or more lesions. |
| 96567 | Photodynamic therapy by external application of light to destroy pre-malignant and/or malignant lesions of the skin and adjacent mucosa (e.g., lip) by activation of photosensitive drug(s) each phototherapy exposure session. |
| 96570 | Photodynamic therapy by endoscopic application of light to ablate abnormal tissue via activation of photosensitive drug(s); first 30 minutes. |
| 96571 | Photodynamic therapy by endoscopic application of light; each additional 15 minutes. |
| 96573 | Photodynamic therapy by external application of light to destroy premalignant lesions of the skin and adjacent mucosa with application and illumination/activation of photosensitizing drug(s) provided by a physician or other qualified health care professional, per day. |
| 96910 | Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B. |
| 96912 | Photochemotherapy; psoralens and ultraviolet A (PUVA). |
| 96913 | Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4-8 hours of care under direct supervision of the physician (includes application of medication and dressings). |
| 96920 | Laser treatment for inflammatory skin disease (psoriasis). |
| E0200 | Heat lamp, without stand (table model), includes bulb, or infrared element. |
| E0205 | Heat lamp, with stand, includes bulb, or infrared element. |
| E0691 | Ultraviolet light therapy system. |
| E0692 | Ultraviolet light therapy system. |
| E0693 | Ultraviolet light therapy system. |
| E0694 | Ultraviolet light therapy system. |
| J7308 | Aminolevulinic acid HCL for topical administration, 20%, single unit dosage form (354 mg). |
| J7309 | Methyl aminolevulinate (MAL) for topical administration, 16.8%, 1 gram [product discontinued]. |
| J7345 | Aminolevulinic acid hcl for topical administration, 10% gel, 10 mg. |
| L70.0-L70.9 | Acne (all codes L70.0 through L70.9). |
| L73.2 | Hidradenitis suppurativa |
Provider Actions & Billing Guidance
Do not bill covered CPT/HCPCS for listed experimental therapies
Providers should not bill the listed CPT and HCPCS codes for the indications in this Clinical Policy Bulletin because these treatments are considered experimental and investigational for acne or hidradenitis suppurativa.
Policy review and history available
The Clinical Policy Bulletin and its Review History pages contain the full coverage criteria, definitions, and review notes. Refer to the policy for details; the document shows last review date 09/14/2023, effective date 04/25/2003, and next review 07/11/2024.
Background and Evidence Summary
Evidence summaries report many small, heterogeneous studies of light-, laser-, and photodynamic-based therapies for acne and acne scarring with mixed results, short follow-up, and limited comparative data versus established treatments.
Photodynamic therapy (PDT) with topical photosensitizers (ALA or MAL) shows the most consistent short-term improvements in several trials and reviews, but studies are often small, associated with notable adverse effects (pain, erythema, edema, crusting, hyperpigmentation), and lack long-term comparative randomized trials to establish superiority or optimal protocols.
Other modalities (lasers, IPL, photopneumatic therapy, LED/blue/red light, nano- and nanoparticle approaches, nano-pulse stimulation, ICG- or chlorin e6–based PDT) have preliminary or pilot data suggesting potential benefit in select small series or case reports, but overall evidence is limited, inconsistent, and insufficient to support routine use or to demonstrate durable long-term outcomes.
| Study / Source | Key Finding |
|---|---|
| Haedersdal et al (2008) | 16 RCTs + 3 CTs (587 patients); optical treatments may improve inflammatory acne short-term with most consistent outcomes for PDT (up to 68% improvement; ALA/MAL + red light) |
| Hamilton et al (2009) | 25 trials (694 patients); mixed results—some short-term benefit with blue/red light and PDT; PDT benefits but side-effects and not superior to topical adapalene in some comparisons |
| Barbaric et al (2018) Cochrane | 71 RCTs (4,211 participants); overall limited/low-quality evidence; many modalities showed no clinically significant effects; adverse events variably reported |
| Zhang et al (2017) split-face RCT | n=12: 5% ALA-PDT with red light vs IPL—red light superior for lesion reduction; IPL better tolerated |
| Nicklas et al (2019) RCT | n=46: ALA-PDT vs doxycycline+adapalene—PDT had greater lesion reduction at 6 and 12 weeks; small sample limits conclusions |
| Darne et al (2011) 1,450-nm laser RCT | n=38 split-face: 1,450-nm laser showed no difference vs control in inflammatory lesion count or acne grade |
| Narurkar et al (2013) / Photopneumatic multi-center trial | n=41: photopneumatic + profusion topical agents—69% reduction in inflamed lesions at 3 months (physician assessment) |
| Zheng et al (2014) systematic review | 14 RCTs (n=492): various PDT protocols effective on inflammatory lesions; ALA+red light optimal; more RCTs needed |
| Lu et al (2020) meta-analysis of IPL | 8 RCTs (n=450): IPL less effective than controls for inflammatory lesions; inferior to PDT and PDL for some comparisons; common AEs erythema and pain |
| Posadzki & Car / Reviews on light therapies | Evidence for light therapies weak/inconclusive; red-light MAL-PDT only associated with small improvements not clearly clinically significant |
| Serini et al (2019) 5% ALA gel PDT | n=35 proof-of-concept: red-light PDT with 5% ALA thermos-setting gel produced ~70% GAG score reduction with good tolerability (medium-term) |
| Katz et al (2023) CellFX (Nano-Pulse Stimulation) | Feasibility n=17 (13 completed): CellFX-treated back areas showed 82% lesion reduction at 90 days; common erythema and hyperpigmentation; lidocaine required |
| Shi et al (2022) Tri-needle pretreatment + ALA-PDT RCT | n=48: tri-needle pretreatment improved effectiveness and reduced pain vs ALA-PDT alone but increased edema |
| Lee et al (2023) methylene blue nano-formulation | n=24: 5 weekly MB nano-formulation PDT showed marked lesion reduction and safety; preliminary evidence |
| Park et al (2020) gold nanoshell photothermal therapy (cases) | 2 refractory acne cases improved after 3 sessions with 3–4 month follow-up; preliminary case evidence |
| Artounian et al (2021) gold/silver nanoparticle systematic review | 16 original articles; nanoparticles promising adjuncts with phototherapy but clinical RCT evidence limited; further RCTs needed |
| Wang et al (2017) Chlorin e6-mediated PDT (preclinical) | In vitro and in vivo anti-inflammatory effects—down-regulated inflammatory markers and signaling pathways; supports feasibility |
| Choi et al (2018) ICG-based PDT | In vitro bactericidal effects; retrospective clinical analysis (n=21) showed decreased acne grade—preliminary findings needing validation |
| Modena et al (2020) Erbium lasers systematic review | 17 trials (453 patients): erbium glass/YAG lasers promising short-term with minimal AEs; long-term data limited |
| Erceg et al (2013) PDL review | PDL may be effective and safe for localized inflammatory acne (recommendation grade B) but most data not from RCTs |
| Wu et al (2021) red light meta-analysis | 13 RCTs (422 subjects): no significant difference vs traditional therapies for inflammatory or non-inflammatory lesions; mild AEs |
| Ash et al (2015) home-use blue LED RCT | n=41 (treatment n=26): blue LED reduced inflammatory lesions by ~50% vs +2.45% control at 12 weeks; small study, short follow-up |
| Cohen et al (2022) home-based devices review | 37 trials (19 RCTs): some home devices (LED-BL/RL) appear safe/effective but RCT evidence limited and heterogeneous |
Definitions
PDT: Photodynamic therapy; application of a topical photosensitizer (e.g., ALA or MAL) followed by activation with light to destroy target tissue or bacteria.
ALA: 5-aminolevulinic acid, a topical photosensitizer used in photodynamic therapy.
MAL: methyl aminolevulinate, a topical photosensitizer used in photodynamic therapy.
Photopneumatic therapy: Device combining negative pressure (vacuum) with broadband pulsed light to treat acne by evacuating sebum and delivering light.
ICG: indocyanine green, a photosensitizer studied in PDT for acne.
Revision History
Policy effective date: 2003-04-25
Last review of the Clinical Policy Bulletin: 2023-09-14
Planned next review date: 2024-07-11
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