Cigna Rosacea Procedures - (0482) Form

Coverage Policy

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies.

Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies.

In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.

Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines.

In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

This Coverage Policy addresses nonpharmacologic treatments for rosacea, including rhinophyma.

Coverage Policy

Coverage for the treatment of rosacea varies across plans. Please refer to the customer’s benefit plan document for coverage details. Please refer to the applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for rosacea medications.

If coverage for treatment of rosacea is available, the following conditions of coverage apply.

Surgical excision, with or without skin grafting or flap reconstruction for the treatment of advanced nodular rhinophyma is considered medically necessary when the rhinophyma is documented to be causing a functional impairment (e.g., airway obstruction) AND frontal, lateral, and worm’s eye photographs document the condition.

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The treatment of the untoward cosmetic effects associated with rosacea (e.g., telangiectasia, erythema) is considered cosmetic in nature and not medically necessary.

Rosacea treatments that are considered cosmetic in nature and not medically necessary include, but are not limited to:

• dermabrasion
• chemical peels of any type
• intense pulsed light (IPL)
• laser therapy (e.g., pulsed dye)

General Background

Rosacea is a chronic disorder affecting the facial skin and is associated with blushing. Rosacea develops slowly, starting with redness around the cheeks and worsening to additional symptoms and affecting other parts of the face. The condition affects approximately 5% of adults, typically over the age of 30. Although rosacea occurs more often in women, the presentation can be more severe when it occurs in men.

In general, treatment of rosacea is aimed at improving the untoward cosmetic effects associated with the condition. Surgery may be indicated in a select subset of individuals with advanced nodular rhinophyma (a skin disorder of the nose causing thickened, irregular skin), when the condition is causing a significant functional impairment.

The signs and symptoms of rosacea vary from person to person and are often intermittent. The clinical conditions of rosacea include (American Academy of Dermatology [AAD], 2023a):

• erythema or flushing of the face/neck
• pimples, papules and/or pustules (may appear as small red bumps)
• nasal bumps (rhinophyma) – an uncommon sign seen especially in untreated rosacea
• red lines (telangiectasia), which appear or become more noticeable when the skin is flushed
• facial dryness, burning, stinging or itching

Historically, rosacea was classified as one of the following four subtypes: erythematotelangiectatic (vascular), papulopustular (inflammatory), phymatous/glandular, or ocular. However, rosacea is now considered a consistent multivariate disease process with multiple clinical manifestations, rather than distinct subtypes of disease.

A diagnosis of rosacea may be made in the presence of either of the following diagnostic phenotypes: fixed centrofacial erythema in a characteristic pattern that may periodically intensify, or phymatous changes. Alternatively, a diagnosis made be made in the presence of two or more major phenotypes: papules and pustules, flushing, telangiectasia, or ocular manifestations.

Secondary signs and symptoms may appear with one or more diagnostic or major phenotypes and may include the following:

• burning or stinging
• edema
• dry appearance

Ocular involvement may occur in the presence or absence of skin manifestations. Signs and symptoms of ocular rosacea may include blepharitis, foreign body sensations, lid margin telangiectasia, tear abnormalities, meibomian gland inflammation, conjunctivitis, frequent chalazion, and rarely, corneal ulcers and vascularization.

Rosacea is most commonly diagnosed in individuals with lightly-pigmented skin (Fitzpatrick skin phototypes I and II). However, skin pigmentation may mask some of the signs of rosacea, potentially leading to the under-diagnosis of patients with moderately to highly pigmented skin.

Delayed diagnosis may lead to more advanced disease, inadequate treatment, disfigurement, and in the case of ocular rosacea, impairment or loss of sight. Strategies to enhance timely diagnosis of rosacea in individuals with darker skin include an increased awareness that erythema may not be readily visible in all individuals; use of dermoscopy to detect telangiectasia; use of diascopy or photography against a dark blue background to visualize erythema; and attentiveness to other characteristic signs of rosacea concentrated in the central face (e.g., dry appearance, edema, and hyperpigmentation).

Medical Coverage Policy: 0482 Treatments

The symptoms of rosacea can be treated and controlled, but there is no cure. Since the pathophysiology of rosacea is unknown, the treatments or therapies for rosacea empirically target the signs and symptoms of the disease. Treatment for rosacea is usually performed solely for cosmesis, with the primary purpose being to improve the appearance of the skin. However, in certain rare cases of advanced nodular rhinophyma, the condition causes a functional impairment such as airway obstruction, and thus surgical therapy may be indicated.

In most patients who receive treatment, symptom suppression can be achieved, though flare-ups can occur. Prior to initiating therapy, any potential trigger factors are considered. Triggers are both exposures and situations that can cause a flare-up of the skin changes and flushing in rosacea. Trigger factors are specific to each individual and do not affect every person. Common triggers include: hot or cold temperature, wind, hot drinks, exercise, spicy food, alcohol, emotions, topical products that irritate the skin or impair barrier function, menopausal flushing, and medications that promote flushing. It is recommended that those trigger factors that induce flushing be avoided.

Patients are recommended to use a broad-spectrum, gentle sunscreen daily, avoid midday sun, and use protective clothing when in the sun. The untoward cosmetic signs of rosacea may be camouflaged with nonirritating concealers and cosmetics. A combination of treatments is often prescribed, depending on the individual’s needs. Sometimes both an oral antibiotic and a topical medication are prescribed (Ferri, 2023; Maier and Helfrich, 2022; Kupiec Banasikowska, 2021).

Erythema or Flushing:

Electrosurgery, intense pulsed light (IPL), and laser surgery or vascular lasers are often used to destroy visible blood vessels below the skin to reduce erythema. Multiple IPL or laser therapy treatments may be needed to achieve the optimum results. Anecdotal evidence indicates treatment of rosacea with medications that reduce flushing may include anticholinergic medications (e.g., glycopyrrolate), alpha-2 adrenergic agonists (e.g., brimonidine), beta-blockers, clonidine, and psychotropic medications. These medications can have serious side effects that should be weighed against potential benefits. These therapies or treatments do not treat the underlying cause of rosacea but rather the red appearance of the skin which is associated with rosacea; therefore, these treatments are cosmetic in nature.

Papules and Pustules:

Topical medications (e.g., metronidazole) and/or oral antibiotics (e.g., doxycycline) are frequently prescribed. The oral antibiotics tend to work faster than the topical medications. Glycolic acid peels, washes, and creams have been proposed to be used in combination with oral antibiotics. Chemical peel solutions damage the outer layers of the skin and stimulate collagen formation, resulting in dermal regeneration, thereby improving the appearance of the skin. Alpha-hydroxy acids (AHA), such as glycolic, lactic, or fruit acid, are used in superficial peeling to rejuvenate and resurface sun-damaged skin, soften the appearance of pores, treat fine wrinkles and reduce uneven pigmentation. For severe cases, off-label use of the retinoid isotretinoin may be used to help shrink thickened facial skin and diminish nodular rosacea. Due to the serious side effects of isotretinoin, it is commonly reserved for cases in which multiple treatments have failed.

Ocular Rosacea:

It is recommended that those patients with eyelid inflammation cleanse their eyelids often by gently scrubbing the eyelids with diluted baby shampoo or an over-the-counter eyelid cleaning product and apply warm compresses several times daily. Oral antibiotics are used to treat the ocular symptoms of rosacea. A short course of topical corticosteroid solution may be useful for symptomatic relief of ocular rosacea. It is recommended that ocular steroid therapy be initiated and managed by an ophthalmologist because experience with this treatment is limited. Liquid tears are useful for dry eyes and relief of ocular itching.

Rhinophyma:

Early treatment of rhinophyma is recommended to help prevent the condition from progressing and becoming more difficult to treat.

Changes due to rhinophyma can become permanent. The nasal skin can be erythematous with telangiectasias and sometimes become purple in color. In severe cases, the skin can have pits, fissures, and scarring. Infection and bleeding may occur. In the rare advanced stages, rhinophyma can result in collapse of the nostrils, resulting in airway obstruction.

Rhinophyma does not respond well to medical therapy. The condition can be corrected surgically, but it may recur. Generally, cosmetic surgery is performed to remove thickened tissue that can appear around the nose, and sculpt areas to a more normal appearance. Such cosmetic treatments may include dermabrasion, cryosurgery, electrosurgery, and/or laser surgery.

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Surgical procedures are indicated for the treatment of advanced nodular rhinophyma, which may result in functional impairment, such as airway obstruction. The surgical procedures can broadly be divided into full excision of the abnormal tissue and repair of the defect by graft or flap, and partial excision leaving the lower part of the pilosebaceous unit intact (superficial decortication). It has been reported that the latter appears to result in better results and is the treatment of choice. Treatment options may be combined to obtain best results. Frontal, lateral, and worm’s eye photographs may be taken to document the condition (Dick and Patel, 2022; Ferri, 2023; Maier and Helfrich, 2022).

Laser and Intense Pulsed Light (IPL) Treatments:

An ever-increasing number of lasers and a non-laser light therapy called intense pulsed light (IPL) are available for treating rosacea. Data on the effectiveness and safety of lasers and non-laser light therapy is limited. While there is some evidence that laser and light therapies may reduce the symptoms of rosacea, studies are limited by small study populations, variable patient selection criteria, treatment protocols, study design, and short term follow up (Hayes, 2020; van Zuuren, et al., 2015).

Most of what is known comes from observations made while treating individual patients. It is recommended that patients continue to consult their primary care physician or dermatologist for treatment and avoid personal rosacea triggers. These therapies or treatments do not treat the underlying cause of rosacea but rather the appearance of the skin; therefore, these treatments are cosmetic in nature.

U.S. Food and Drug Administration (FDA)

Several light and laser systems have been cleared for marketing via the 510(k) Premarket Notification process. Such devices are categorized as Class II devices. Intense pulsed light is referred to by a variety of trade names or service marks (e.g., FotoFacial™, PhotoFacial™, EpiLight™, PlasmaLight™, Venus Versa™ ). The FDA classifies laser and light therapies as procedures; therefore, long-term studies are not required. There are a variety of lasers including, but not limited to (Zachary and Kelly, 2018):

• argon
• erbium: yttrium aluminum garnet (Er:YAG)
• neodymium: yttrium aluminum garnet (Nd:YAG)
• potassium-titanyl-phosphate (KTP)
• pulsed dye (e.g., Candela V-Beam)
• krypton
• carbon dioxide (CO2)
• copper-bromide

Professional Societies/Organizations

American Academy of Ophthalmology (AAO): The 2018 AAO Preferred Practice Pattern for blepharitis supported the use of topical azelaic acid, topical ivermectin, brimonidine, doxycycline and isotretinoin as effective treatments for patients with systemic rosacea. The guideline stated that while intense pulsed light has been used as a novel therapy for the treatment of meibomian gland dysfunction, there is insufficient evidence to determine its effectiveness in patients with rosacea.

Use Outside of the US

In 2021, the British Association of Dermatologists (BAD) published an updated guideline on the management of rosacea. The section on procedural therapies included recommendations to:

• Consider pulsed dye laser, Nd:YAG laser, or intense pulsed light for rosacea where the main presenting feature is persistent facial erythema (weak recommendation).
• Consider nasal de-bulking for persons with significant rhinophyma by laser ablation or surgical intervention (weak recommendation).

More generally, BAD recommended to avoid the long-term use of oral antibiotics; limit exposure to known aggravating factors (e.g., sun exposure, alcohol); classify patients according to phenotypes using objective clinical signs and subjective symptoms; and to consider the need for psychological support or interventions for individuals with rosacea who experience anxiety or depression (Hampton, et al., 2021).

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