CurrentAetnaPolicy 0547

Rosacea

Clinical coverage policy for diagnosis and management of rosacea, including medical treatments, surgical interventions for rhinophyma, experimental/investigational therapies, and coding guidance; applies to Aetna plan administration.

Policy Summary

PayerAetna

PolicyRosacea

Policy CodePolicy 0547

Change TypeNo material change

Effective DateJun 29, 2001

Next Review DateJun 13, 2024

Key ActionDocument bleeding or infection refractory to medical therapy when requesting excision or shaving for rhinophyma.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1policy number

Rhofademedically necessary

Multipleinvestigational

962trial subjects (ivermectin)

440oxymetazoline pts

64document chunks

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Coverage Criteria and Evidence

Medical Necessity - General and Rhinophyma

Covered when ALL of the following are met

Medical treatment: Aetna considers medical treatment of rosacea medically necessary.

general coverage for medical therapies

Surgical treatment of disfigurement from rosacea (e.g., scarring and telangiectasias) is considered cosmetic.

cosmetic exclusion applies

Rhinophyma exception: Excision or shaving of rhinophyma is medically necessary for the treatment of bleeding or infection refractory to medical therapy (e.g., the need for repeated cautery of bleeding telangiectasias or frequent courses of antibiotics for pustular eruptions).refractory bleeding or infection

document prior failed medical therapy

Topical oxymetazoline (Rhofade) is medically necessary for the treatment of persistent facial erythema associated with rosacea in adults.adults with persistent facial erythema

specific drug coverage stated; FDA indication noted

Experimental and Investigational Procedures and Treatments

The following are considered experimental and investigational because effectiveness has not been established

Diagnostic tests listed: Evaluation of the gastro-intestinal microbiome; measurement of serum bilirubin, uric acid and zonulin levels; measurements of serum chemokines (including CCL2, CCL3, CCL20, CXCL1, CXCL8, CXCL9, CXCL10, and CXCL12); measurements of serum endocan; reflectance confocal microscopy and spectrometry for rosacea assessment and monitoring of therapy.

listed diagnostic/tests considered experimental

Treatments listed: Botulinum toxin (including Microbotox), Helicobacter pylori therapy, hydroxychloroquine, intense pulsed light (for ocular rosacea), nano-emulsion of pioglitazone, photodynamic therapy, phytochemical and botanical therapies, polyphenols, recombinant bovine basic fibroblast growth factor gel, topical calcineurin inhibitors (e.g., pimecrolimus and tacrolimus).

listed treatments considered experimental

Evidence summaries (no policy criteria specified)

Evidence summaries and key trial outcomes for therapies evaluated in rosacea

Topical ivermectin: Phase III RCT (Taieb et al. 2015) showed once-daily ivermectin 1% cream superior to twice-daily metronidazole 0.75% for reduction of inflammatory lesions and Investigator Global Assessment outcomes in moderate-to-severe papulopustular rosacea (n=962).

chunk 19

Topical oxymetazoline: Phase II and multiple phase III trials (DuBois 2018; Kircik 2018; Draelos long-term study 52 weeks) demonstrated oxymetazoline 1% once daily reduces persistent facial erythema versus vehicle with acceptable safety and sustained effect over 52 weeks.

chunks 25,26,28

Botulinum toxin intradermal (microbotox): Small uncontrolled and pilot studies report improvement in facial erythema and flushing; authors state larger randomized trials are required to confirm efficacy.

background evidence; relevant trials summarized in policy

Evidence summaries — investigational/ emerging treatments and biomarkers

Evidence summaries and investigational findings (no policy decision language in these chunks).

rbFGF topical gel evidence: Randomized, single-blind, vehicle-controlled study (n=1,287) of rbFGF gel in Demodex mite-induced rosacea reported higher total effective rates for erythema, papules, desquamation and dryness at 2, 4, and 6 months versus vehicle, with favorable histologic changes; authors call for double-blind validation.

chunks 36-37

Hydroxychloroquine evidence: Preclinical and small clinical observations indicate HCQ may reduce inflammatory lesions and erythema via modulation of mast-cell–related pathways; larger clinical trials are required to verify safety and effectiveness.

chunk 38

Biomarkers (bilirubin, uric acid, zonulin, chemokines, endocan): Multiple small studies report associations between rosacea and biomarkers (e.g., UA, CRP, bilirubin, zonulin, chemokines CCL/ CXCL families, serum endocan); these findings require further validation and are not established for routine clinical use.

chunks 42-50 and policy commentary

Surgical procedures intended to correct or improve appearance (cosmetic surgery) are excluded from coverage under Aetna standard benefit plans. For rosacea this includes surgical treatment of disfigurement such as scarring and telangiectasias. Always check the member's benefit plan documents for specific coverage details and any applicable exceptions.

The bulletin does not list additional explicit coverage exclusions beyond the cosmetic surgery provision, but identifies multiple botanical, phytochemical and polyphenol therapies (and similar novel topical agents) as investigational or insufficiently studied. Systematic reviews cited found promising signals for some botanical agents and polyphenols, but the available studies are limited by methodological weaknesses and small sample sizes, and larger randomized controlled trials are needed to establish safety and effectiveness.

UpToDate reviews cited in the document do not recommend routine measurement of serum bilirubin, uric acid, or zonulin, and do not describe reflectance confocal microscopy (RCM) or spectrometry as standard management tools for rosacea. The policy therefore treats these laboratory and noninvasive measurement techniques as investigational pending further validation.

Clinical Policy Bulletins are informational tools to assist in administering plan benefits and do not constitute offers of coverage or a complete description of a member's benefit plan. Actual coverage decisions are governed by the member's contract, certificate, or summary plan description; providers should consult those documents for definitive coverage rules.

The policy identifies a range of procedures and diagnostic tests as experimental and investigational for rosacea because effectiveness has not been established. Examples listed include reflectance confocal microscopy and spectrometry for assessment and monitoring, photodynamic therapy, and botulinum toxin injections (including Microbotox). Corresponding CPT/HCPCS codes for imaging and botulinum toxin J-codes are referenced in the coding sections when applicable.

The document summarizes systematic reviews that found limited and low-quality evidence for many botanical and phytochemical therapies. While some studies report reductions in erythema and lesion counts, methodological limitations and small sample sizes mean the evidence is insufficient to support routine coverage of these agents at this time.

Evidence for noninvasive imaging modalities (e.g., RCM, spectrometry) and for photodynamic therapy is preliminary. Systematic reviews report promising research uses—such as RCM for Demodex counts, spectrometry for objective erythema quantification, and small PDT studies showing clinical responses—but note variable methodological quality, small sample sizes, and the need for larger, well-designed trials before these approaches can be considered established standard-of-care options.

Coding and Billing Guidance

Covered CPT Codes (if selection criteria met)CPTCovered

10040	Acne surgery (e.g., marsupialization, opening or removal of multiple milia, comedones, cysts, pustules)[for acute rosacea].
30120	Excision or surgical planing of skin of nose for rhinophyma [for the treatment of bleeding or infection refractory to medical therapy (i.e., the need for repeated cautery of bleeding telangiectasias or frequent courses of antibiotics for pustular eruptions)].

CPT Codes Not Covered for Indications ListedCPTNot Covered

15780	Dermabrasion; total face (e.g., for acne scarring, fine wrinkling, rhytids, general keratosis).
15781	Dermabrasion; segmental, face.
15782	Dermabrasion; regional other than face.
15783	Dermabrasion; superficial, any site (e.g., tattoo removal ).
15788	Chemical peel, facial; epidermal.
15789	Chemical peel, facial; dermal.
15792	Chemical peel, nonfacial; epidermal.
15793	Chemical peel, nonfacial; dermal.
17000	Destruction (e.g., laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), premalignant lesions (e.g., actinic keratoses); first lesion.
17003	Destruction, premalignant lesions; second through 14 lesions (add-on).

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1/3

HCPCS/J-codes Not Covered for Indications Listed (botulinum toxins)HCPCSNot Covered

J0585	Injection, onabotulinumtoxinA, 1 unit.
J0586	Injection, abobotulinumtoxinA, 5 units.
J0587	Injection, rimabotulinumtoxinB, 100 units.
J0588	Injection, incobotulinumtoxinA, 1 unit.

ICD-10 Codes Covered if Selection Criteria MetICD-10Covered

L53.9	Erythematous condition, unspecified [persistent facial erythema].
L71.0	Rosacea.
L71.9	Rosacea, unspecified.

ICD-10 Codes Not Covered for Indications ListedICD-10Not Covered

I78.0	Disease of capillaries.
I78.9	Disease of capillaries, unspecified.
L90.5	Scar conditions and fibrosis of skin.

Demodex concentration threshold — clinician guidance

Demodex concentration threshold> 5/cm^2 — threshold at which cited clinicians consider topical crotamiton 10% or metronidazole

Clinical action when threshold exceededUse topical crotamiton 10% or topical metronidazole per cited clinical practice

Measurement contextThreshold reported as used by clinicians screening for Demodex folliculorum when evaluating refractory or suspected Demodex-associated rosacea

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization for Procedural Codes

Prior authorization for certain procedural CPT/HCPCS codes may apply — providers should confirm PA requirements with the payer prior to scheduling. Examples of CPT codes listed as covered only when selection criteria are met include 10040 (acne surgery) and 30120 (excision or surgical planing of nose for rhinophyma when used for bleeding or infection refractory to medical therapy). Several CPT/HCPCS and J-codes for interventions considered experimental/investigational or cosmetic are listed as not covered for the indications in this bulletin.

Covered CPT examples when selection criteria met: 10040 (acne surgery); 30120 (excision/surgical planing of nose for rhinophyma when bleeding/infection refractory to medical therapy).
Codes listed as not covered (for indications in CPB): multiple dermabrasion/chemical peel codes (15780–15793), destruction codes (17000–17004), and various HCPCS/J-codes for botulinum toxin injectables (J0585–J0588) and others.
Always verify current prior authorization rules with Aetna; the bulletin lists code status but operational PA steps/authorization triggers are not specified here.

Note

Prior Authorization Not Specified in Bulletin

Background and Scope

Rosacea is a chronic, multifactorial inflammatory skin disorder typically affecting middle-aged adults. It is characterized by persistent facial erythema, visible telangiectasias, inflammatory papules and pustules, and in some patients phymatous changes such as rhinophyma. Management is severity-dependent and ranges from topical therapies for mild disease to oral antibiotics or isotretinoin for more severe or refractory presentations; laser and other procedural approaches are used primarily for cosmetic signs, and surgical debulking is used for rhinophyma when medically indicated.

Definitions and Key Terms

Rhinophyma (phymatous rosacea)

DefinitionPhymatous subtype of rosacea characterized by soft tissue and sebaceous hyperplasia of the nose

Typical treatmentsOften treated surgically by electrosurgery, laser excision, or surgical debulking

Coverage noteBecause rhinophyma and telangiectasias do not cause functional limitations, their treatment is generally considered cosmetic unless treating bleeding or infection refractory to medical therapy

Papulopustular rosacea (PPR)

DefinitionSubtype of rosacea characterized by inflammatory papules and pustules

Severity targeted in trialsClinical trials cited targeted moderate-to-severe papulopustular rosacea (PPR)

Policy Revision History

2023-08-10last_reviewLatest

Clinical policy last reviewed on 2023-08-10.

2001-06-29effective_date

Policy originally became effective on 2001-06-29.

2024-06-13next_review

Next scheduled policy review on 2024-06-13.

Policy Summary

PayerAetna

PolicyRosacea

Policy CodePolicy 0547

Change TypeNo material change

Effective DateJun 29, 2001

Next Review DateJun 13, 2024

Key ActionDocument bleeding or infection refractory to medical therapy when requesting excision or shaving for rhinophyma.

SourceLink

On This Page

Light-based therapies (IPL, pulsed dye laser): Systematic reviews and clinical summaries indicate IPL, pulsed dye laser and KTP may improve facial erythema and telangiectasias; existing evidence includes uncontrolled studies and some randomized split-face trials.

documented in evidence summaries

Botanical, polyphenol, and alternative topical agents: Systematic reviews suggest potential benefit for several botanical extracts and polyphenols but studies are small and methodologically limited; further randomized trials are needed.

chunks 20,33

Topical minocycline foam (FMX103): Phase II RCT of topical minocycline foam showed 1.5% and 3% once-daily reduced inflammatory lesion counts versus vehicle at 12 weeks and was generally well tolerated; phase III validation pending.

chunk 34

Investigational agents (rbFGF, pioglitazone nano-emulsion): A large single-blind rbFGF gel study in Demodex-associated rosacea reported higher effective rates versus vehicle with histologic improvement; early-stage data for pioglitazone nano-emulsion show anti-inflammatory effects—rigorous trials needed.

chunk 36 and related summaries

Noninvasive imaging and monitoring: Systematic review identified multiple noninvasive imaging and biophysical methods (78 studies); RCM can detect Demodex and spectrometry can quantify erythema but methodological quality is variable and larger validation studies are needed; current RCM data show mite counts change during therapy but have limited predictive value for clinical success.

chunks 42-43

Photodynamic therapy: Systematic review of 9 studies (small sample sizes) reported generally satisfactory clinical responses and tolerable side effects for PDT in rosacea; evidence is preliminary and rigorous RCTs with larger samples and longer follow-up are needed.

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The bulletin excerpts do not specify an operational prior authorization process, explicit prior authorization codes, or step-by-step authorization instructions for photodynamic therapy or other treatments — providers must check the plan-specific authorization portal or contact Aetna to determine whether prior authorization is required for a given service.

No explicit PA requirements or authorization codes provided in these excerpts for photodynamic therapy (PDT) or many other interventions.
Providers should not rely solely on this CPB to determine PA — confirm via plan documents or Aetna provider portal.

Documentation Required

Clinical Policy Bulletin Does Not Define Authorization Steps

This Clinical Policy Bulletin is informational and does not itself define the specific prior authorization steps or codes. It contains only a partial description of plan benefits; treating providers remain responsible for medical decision-making, and coverage is governed by the member's specific benefit plan.

Clinical Policy Bulletins assist in administering plan benefits but do not constitute offers of coverage or medical advice.
Check member's benefit plan documents and Aetna authorization resources for definitive coverage and PA procedures.

Documentation Required

No Explicit Prior Authorization or Documentation Checklist Provided — Provider Responsibilities

No explicit prior authorization triggers or documentation checklists are provided in the bulletin excerpts. When seeking reimbursement, providers should document medical necessity per the policy (e.g., for rhinophyma, document bleeding or infection refractory to medical therapy or functional impairment) and retain clinical records supporting the indication.

For excision/shaving of rhinophyma (CPT 30120) to be medically necessary, document bleeding or infection refractory to medical therapy (e.g., repeated cautery, frequent antibiotic courses) or functional impairment.
For procedures considered cosmetic (telangiectasias, scarring), note exclusion from coverage under standard plans; include benefit verification when submitting claims.

Note

Clinical Trial and Evidence Reporting — Provider Context

Clinical trial and study-level evidence summaries are included in the bulletin to inform clinical context but do not mandate step-therapy or coverage sequencing. Examples: randomized trials of ivermectin versus metronidazole and phase‑III trials of oxymetazoline are summarized; a randomized single‑blind rbFGF trial and systematic reviews (e.g., PDT) are reported.

Phase III randomized trial: ivermectin 1% cream demonstrated superiority to metronidazole 0.75% for inflammatory lesion reduction (Taieb et al., 2015).
Phase III trials and long-term studies: oxymetazoline (Rhofade) shown effective for persistent facial erythema with safety data (Kircik et al., Draelos et al.).
rbFGF randomized single‑blind study documented lesion scores, histological analysis, and 6‑month follow-up; investigators allowed crossover in control group.
Systematic review of photodynamic therapy reported preliminary evidence of safety and efficacy but called for larger RCTs with longer follow-up.

Step Therapy

Stepwise Therapy Expectation for Rosacea

Accepted clinical guidance and the bulletin convey a stepwise therapy expectation for inflammatory rosacea: initial medical management with topical agents (e.g., metronidazole, clindamycin, erythromycin) for mild disease, progressing to oral tetracyclines or erythromycin for moderate disease, and isotretinoin for severe refractory cases. Procedural or surgical interventions (e.g., lasers, electrosurgery) are generally for cosmetic signs like telangiectasias and rhinophyma and may be excluded or require specific documentation.

First-line medical therapy: topical metronidazole, topical azelaic acid, topical clindamycin or erythromycin for mild cases.
Moderate disease: oral tetracyclines or erythromycin.
Severe/refractory disease: isotretinoin or other specialist-directed therapies.
Procedural/surgical interventions for cosmetic concerns are typically considered cosmetic and excluded under standard plans unless specific medical necessity criteria are met (e.g., rhinophyma with refractory bleeding/infection).

Note

Clinical Trials Compare Topical Agents but No Step-Therapy Requirement Specified

Although clinical trials compare different topical agents (for example ivermectin cream vs metronidazole, and oxymetazoline vs vehicle), the bulletin does not impose a required step‑therapy sequencing based on these trials. Coverage determinations should be made according to plan rules and documented medical necessity.

Ivermectin 1% once daily was superior to metronidazole 0.75% twice daily in a phase III trial for inflammatory lesion reduction.
Oxymetazoline demonstrated efficacy versus vehicle for persistent facial erythema in phase III trials; it is FDA-indicated for this use in adults.
No mandatory step-therapy sequence (e.g., must try metronidazole before ivermectin) is specified in these policy excerpts — check plan-specific step-therapy requirements if any.

Common medical therapiesTopical metronidazole, azelaic acid; oral tetracyclines or doxycycline for moderate cases

Persistent facial erythema

DefinitionOngoing facial redness associated with rosacea; assessed by clinician and patient erythema scales (CEA, SSA)

Clinical trial endpointPrimary endpoint in oxymetazoline studies using composite clinician and subject erythema assessments at specified post-dose times

FDA-indicated therapyOxymetazoline hydrochloride cream (Rhofade) is indicated for persistent facial erythema of rosacea in adults

rbFGF gel (recombinant bovine basic fibroblast growth factor)

InterventionRecombinant bovine basic fibroblast growth factor (rbFGF) gel applied topically (reported dose 0.2 g/cm2 up to 8 weeks)

Study contextRandomized, single-blind, vehicle-controlled study in Demodex mite–induced rosacea (n=1,287) reporting higher 'total effective rates' vs vehicle at 2, 4, and 6 months

Outcomes reportedImprovement in erythema, papules, desquamation and dryness; histologic reduction in epidermal hyperplasia and dermal edema

RCM — Reflectance confocal microscopy

DefinitionReflectance confocal microscopy (RCM): a noninvasive imaging technique that can detect Demodex mites and measure skin parameters in rosacea

Research utilityRCM enabled detection of mites (80% baseline → 30% at week 16 → 63% at week 28) and monitoring during topical ivermectin treatment but had limited predictive value for clinical success

LimitationsQuantifying exact mite number and inflammatory/vascular characteristics is challenging due to device limitations; current value mostly in research settings

PDT — Photodynamic therapy

DefinitionPhotodynamic therapy (PDT): use of photosensitizers such as methyl aminolevulinate (MAL) or aminolevulinic acid (ALA) with light sources for rosacea treatment

Evidence summarySystematic review of 9 studies (patient numbers 1–30) reported generally satisfactory clinical responses with tolerable temporary side effects

Evidence statusCurrent evidence is preliminary; rigorous randomized controlled trials with larger samples and longer follow-up are needed

Policy history

Policy effective dateEffective: 06/29/2001

Last review date08/10/2023

Next review date06/13/2024