Aetna Phototherapy for Acne Coverage Update

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:

Bioresponsive nanoarchitectonics-integrated microneedle patch

Chlorin e6-mediated photodynamic therapy (PDT)

Gold nanoshell-mediated photothermal therapy

Gold and silver nanoparticles, alone or in combination with phototherapy

Indocyanine green-based PDT

Intense pulsed light

Laser (e.g., the AviClear Laser System, Candela Smooth Beam Laser System, Erbium glass laser, Erbium YAG laser, fractional photothermolysis, pulsed dye laser therapy, and Nd:YAG laser therapy)

Light-emitting diode therapy

Nano-pulse stimulation (e.g., the CellFX System)

Non-ablative fractional photothermolysis prior to aminolevulinic acid (ALA)-PTD

Photochemotherapy (see CPB 0205 - Phototherapy and Photochemotherapy (PUVA) for Skin Conditions)

Photodynamic therapy (e.g., the ClearLight Acne PhotoClearing System, Omnilux Blue Photo Dynamic Therapy)

Photodynamic therapy (Blue Light Therapy) with topical aminolevulinic acid (Levulan Kerastick) or topical methylene blue nano-formulation

Photopneumatic therapy

Tri-needle pretreatment combined with ALA-PDT

Home-based devices including those that deliver heat or pulsed heat, laser therapy, light or pulsed light devices, suction, ultraviolet therapy, or any combination of the above

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:

Laser therapy (e.g., pulsed dye laser therapy, Nd:YAG laser therapy)

PDT (blue light therapy) with topical 5-ALA or Levulan

Phototherapy (light therapy)

Experimental and Investigational for Cystic Acne of the Scalp

Aetna considers the following experimental and investigational for cystic acne of the scalp:

Combined surgery and photodynamic therapy (PDT)

Coding — Not Covered / Cosmetic

CPT codes not covered for indications listed in the CPBCPTNot Covered

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).

1–10 of 12

1/2

HCPCS codes not covered for indications listed in the CPBHCPCSNot Covered

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.

ICD-10 codes not covered for indications listed in the CPBICD-10Not Covered

L70.0-L70.9	Acne (all codes L70.0 through L70.9).
L73.2	Hidradenitis suppurativa

Provider Actions & Billing Guidance

Billing Rule

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.

17110
17111
96567
96570
96571
96573
96910
96912
96913
96920
96921
96922
E0200
E0205

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

2003-04-25Effective date

Policy effective date: 2003-04-25

2023-09-14Most Recent ReviewLatest

Last review of the Clinical Policy Bulletin: 2023-09-14

2024-07-11Planned Next Review

Planned next review date: 2024-07-11